Pregnancy in Diabetes, Type 1 Diabetes Mellitus
Conditions
Keywords
type 1 diabetes mellitus, pregnancy, hybrid closed-loop therapy, artificial pancreas therapy, sensor-augmented pump therapy
Brief summary
In pregnancies associated with diabetes, lowering glucose to the recommended targets to prevent adverse health outcomes often leads to significant hypoglycemia. Hybrid closed-loop (HCL) therapy, automated insulin delivery using an insulin pump getting feedback from a continuous glucose monitor (CGM), may improve outcomes. This exploratory, novel pilot feasibility randomized clinical trial will evaluate pregnant women with type 1 diabetes (T1D) on HCL therapy or Sensor-Augmented Pump Therapy (SAPT, non-communicating pump and CGM) from the 2nd trimester, throughout pregnancy, and 4-6 weeks post-partum. Comparisons will be made on safety (Specific Aim \[SA\] 1), indices of glycemic variability and fear of hypoglycemia (SA 2), and quality of life and device satisfaction (SA 3) between groups. Exploratory SA 4 will compare maternal and fetal outcomes between groups. Safety data will include episodes of severe hypoglycemia requiring 3rd party assistance, diabetic ketoacidosis, and skin reactions. Glycemic control will be measured by CGM time spent in glucose ranges (\<63, 63-140, \>140 mg/dL) and other measures of glycemic variability. Subjects will fill out surveys (Fear of Hypoglycemia, a quality of life survey, and 2 questionnaires about device satisfaction) at baseline, throughout gestation, and early post-partum. Data on maternal and fetal outcomes will be collected. Findings will reveal the safety profile and glucose control with a novel therapy for pregnant women with type 1 diabetes.
Detailed description
This is a two-center, prospective, 'open-label', single-blind, investigator-initiated randomized controlled pilot study evaluating hybrid closed-loop (HCL) insulin delivery among pregnant women with T1D compared with sensor-augmented pump therapy (SAPT) throughout most of gestation and the first 6 weeks of the post-partum period at the Barbara Davis Center for Diabetes and Ohio State University. Up to 37 women will be enrolled at ≤11 weeks gestation, sign informed consent, and begin a run-in phase. At baseline, the investigators will obtain data about demographics, health history, pregnancy history, and medication use. The investigators will conduct a physical exam, download diabetes devices already in use by subjects, obtain blood and urine tests, and administer validated questionnaires (Hypoglycemia Fear Survey, MOS Short-Form 36 \[SF-26\], INSPIRE Questionnaire, Insulin Delivery Satisfaction Survey \[IDSS\], and Glucose Monitoring Satisfaction Survey \[GMSS\]). During run-in, women will wear a CGM, fill out log sheets (glucose levels, insulin doses, carbohydrate intake, exercise), upload the CGM, and be in contact with research staff. Eligible subjects will then be trained on study devices for SAPT therapy. At the start of the 2nd trimester, women will be randomized to SAPT or HCL therapy. During pregnancy, women will be seen at each institution monthly for vital signs, HbA1c measurements, device downloads, pump adjustments, medication use, reporting of adverse events and device-related deficiencies, and once a trimester the investigators will additionally obtain serum and urine measurements, specimens for the repository of biological specimens, and ask subjects to fill out questionnaires (Hypoglycemia Fear Survey, SF-35, IDSS, GMSS). Weekly remote contact will be obtained for pump adjustments and reporting of adverse events and device-related deficiencies. Women on HCL therapy will use SAPT during labor and delivery until 3-7 days post-partum, when a study clinician will put them back into auto mode (HCL therapy), if it is safe to do so. The final study visit will take place 4-6 weeks post-partum where the physical exam will be done, HbA1c obtained, device downloads obtained, and final questionnaires submitted (as above plus a post-partum survey). Medical records of the labor and delivery admission will be obtained.
Interventions
DEVICEHybrid closed-loop therapy
Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
DEVICESensor-augmented pump therapy
Insulin pump + non-communicating CGM
Sponsors
Juvenile Diabetes Research Foundation
Ohio State University
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Biostatistician is blinded to intervention assignment
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* women with T1D, * pregnant within the first 11 weeks of gestation, * 18 years of age or older, * diabetes duration \>1 year, * using MDI (multiple daily injections) or CSII (continuous subcutaneous insulin infusion) therapy, * willingness to routinely check at least 3-7 blood glucose measurements per day, * ability and willingness to receive routine and specialty obstetric care throughout the course of the study, * ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy and early post-partum period, * A1C 5.5 - 9%, * willing to participate in the run-in phase and full study (if eligible), and * able to speak, read, and write English
Exclusion criteria
* women with T2D, gestational diabetes, or other type of diabetes (e.g., MODY), - - * pregnancy beyond gestational week 11 or higher, * age \<18 years, * T1D duration \<1 year, * screening A1C \<5.5% or \>9%, * use of basal insulin alone, * use of bolus insulin alone, * extensive skin changes/diseases that inhibit wearing an infusion set, insulin pod, or sensor on normal skin, * known severe allergic reaction to device adhesives within the last 3 months, * unwillingness to use an insulin pump with tubing, * unwillingness to be randomized to study group, * unwillingness to switch from MDI to CSII and CGM (continuous glucose monitor) use (if applicable), * unwillingness to switch from MDI or to change from current insulin pump to HCL system (if applicable), * severe hypoglycemic episode requiring the assistance of a 3rd party within the last 6 months, * non-compliance with run-in phase, * inadequate access to a phone and computer (for downloading devices and web-based communications), * intention to move out of state within the next year, and * any other condition determined by the PI which could make the subject unsuitable for the trial or impairs the validity of the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Episodes of Severe Hypoglycemia | through study completion, an average of 9 months | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance |
| Time Spent With Glucose <54 mg/dL | Through study completion, an average of 9 months | Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose \<54 mg/dL |
| Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Through study completion, an average of 9 months | Indices of glucose control are time spent in the glucose target ranges \<54 mg/dL and \<63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and \>140 mg/dL and \>180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum |
| Fear of Hypoglycemia Score | Through study completion, an average of 9 months | Fear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar. |
| Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar. |
| Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average. |
| Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints. |
| Medical Outcomes Study (MOS) Short-Form 36 Score | through study completion, an average of 9 months | Quality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health |
| INSPIRE Questionnaire Score | through study completion, an average of 9 months | Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). |
| Insulin Delivery Satisfaction Survey (IDSS) Score | through study completion, an average of 9 months | Device acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions. |
| Number of Episodes of Diabetic Ketoacidosis | Through study completion, an average of 9 months | Secondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period. |
| Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia | through study completion, an average of 9 months | Maternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Maternal Outcomes: Number of Participants With Cesarean Delivery | through study completion, an average of 9 months | Maternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Maternal Outcomes: Average Gestational Weight Gain | through study completion, an average of 9 months | Maternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) | through study completion, an average of 9 months | Fetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome | through study completion, an average of 9 months | Fetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants | through study completion, an average of 9 months | Fetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period |
| Glucose Monitoring Satisfaction Survey (GMSS) Score | through study completion, an average of 9 months | Device acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions. |
| Number of Adverse Skin Reactions | through study completion, an average of 9 months | Secondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period |
| Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum |
| Secondary Indices of Glucose Control: J-index | through study completion, an average of 9 months | Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control. Formula: J-Index= 0.001 x (mean blood glucose level + SD)\^2 The J-Index has not been validated in this population of Type 1 Diabetes pregnancies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sensor-augmented Pump Therapy (SAPT) Pregnant women with T1D with use an insulin pump and a continuous glucose monitor but there will be no automated insulin adjustments made by the system.
Sensor-augmented pump therapy: Insulin pump + non-communicating CGM | 12 |
| Hybrid Closed-loop Therapy (HCL) Pregnant women with T1D with use an insulin pump and a continuous glucose monitor with automated insulin adjustments made by the system, but continued meal boluses from the women.
Hybrid closed-loop therapy: Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Hybrid Closed-loop Therapy (HCL) | Sensor-augmented Pump Therapy (SAPT) | Total |
|---|---|---|---|
| Age, Continuous | 31.5 years STANDARD_DEVIATION 4.9 | 30.7 years STANDARD_DEVIATION 3.5 | 31.1 years STANDARD_DEVIATION 4.2 |
| CGM Use Prior to Pregnancy | 12 Participants | 11 Participants | 23 Participants |
| Education Associate's Degree | 0 Participants | 0 Participants | 0 Participants |
| Education Bachelor's Degree | 6 Participants | 5 Participants | 11 Participants |
| Education Doctorate | 0 Participants | 1 Participants | 1 Participants |
| Education High School/General Education Development | 1 Participants | 0 Participants | 1 Participants |
| Education Master's Degree | 5 Participants | 2 Participants | 7 Participants |
| Education Some College | 0 Participants | 3 Participants | 3 Participants |
| Insulin Pump Use Prior to Pregnancy | 12 Participants | 11 Participants | 23 Participants |
| Insurance Type Commercial | 5 Participants | 8 Participants | 13 Participants |
| Insurance Type Government | 1 Participants | 1 Participants | 2 Participants |
| Insurance Type Medicaid | 1 Participants | 0 Participants | 1 Participants |
| Insurance Type Other | 5 Participants | 3 Participants | 8 Participants |
| Multiparity | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Non Hispanic White | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tobacco Use Former | 1 Participants | 3 Participants | 4 Participants |
| Tobacco Use Never | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 10 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 6 / 12 |
Outcome results
Primary
Fear of Hypoglycemia Score
Fear of hypoglycemia is assessed as behavior, worry, and total scores of fear of hypoglycemia determined by the Hypoglycemia Fear Survey of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum. Score Explanation: Change(s) in behavior and/or concerns of diabetics as detected by the hypoglycemia fear questionnaire. Behavior sub-scale score ranges from 10-50, with higher scores indicating more behavioral changes in the participant's daily routine to avoid low blood sugar. Worry sub-scale score ranges from 17-85, with higher scores indicating more worry or concerns because of low blood sugar. Total score ranges from 27-135, with higher scores for both sub-scales indicating more fear and a worse outcome. Subscales are added for the total scale score. Time Points: Baseline: 9 weeks gestation or earlier Visit 7: 18-20 weeks gestation Visit 10: 30-32 weeks gestation Visit 16: 4-6 weeks after delivery
Time frame: Through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Total Score Baseline | 69.4 score on a scale | Standard Error 5.3 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Total Score Visit 7 | 69.0 score on a scale | Standard Error 5.41 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Total Score Visit 10 | 67.3 score on a scale | Standard Error 5.4 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Total Score Visit 16 (postpartum) | 68.0 score on a scale | Standard Error 5.4 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Worry Score Baseline | 40.0 score on a scale | Standard Error 4.26 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Worry Score Visit 7 | 38.3 score on a scale | Standard Error 4.37 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Worry Score Visit 10 | 38.1 score on a scale | Standard Error 4.36 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Worry Score Visit 16 (postpartum) | 38.2 score on a scale | Standard Error 4.36 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Behavior Score Baseline | 29.8 score on a scale | Standard Error 1.85 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Behavior Score Visit 7 | 29.9 score on a scale | Standard Error 1.9 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Behavior Score Visit 10 | 29.0 score on a scale | Standard Error 1.94 |
| Sensor-augmented Pump Therapy (SAPT) | Fear of Hypoglycemia Score | Behavior Score Visit 16 (postpartum) | 29.6 score on a scale | Standard Error 1.94 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Behavior Score Visit 10 | 28.4 score on a scale | Standard Error 1.89 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Total Score Baseline | 69.0 score on a scale | Standard Error 5.12 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Worry Score Visit 10 | 35.9 score on a scale | Standard Error 4.34 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Total Score Visit 7 | 60.5 score on a scale | Standard Error 5.27 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Behavior Score Visit 7 | 29.1 score on a scale | Standard Error 1.89 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Total Score Visit 10 | 64.7 score on a scale | Standard Error 5.35 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Worry Score Visit 16 (postpartum) | 37.6 score on a scale | Standard Error 4.42 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Total Score Visit 16 (postpartum) | 65.3 score on a scale | Standard Error 5.42 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Behavior Score Visit 16 (postpartum) | 27.7 score on a scale | Standard Error 2 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Worry Score Baseline | 39.4 score on a scale | Standard Error 4.1 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Behavior Score Baseline | 29.5 score on a scale | Standard Error 1.79 |
| Hybrid Closed-loop Therapy (HCL) | Fear of Hypoglycemia Score | Worry Score Visit 7 | 31.6 score on a scale | Standard Error 4.26 |
Primary
Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring
Indices of glucose control are time spent in the glucose target ranges \<54 mg/dL and \<63 mg/dL (hypoglycemia), 63-140 mg/dL (time in range), and \>140 mg/dL and \>180 mg/dL (hyperglycemia) of HCL compared to SAPT in women with T1D throughout gestation and the first 4-6 weeks post-partum
Time frame: Through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (1st Trimester) | 3.98 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (2nd Trimester) | 2.84 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (3rd Trimester) | 2.01 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (Postpartum) | 2.66 percentage of time spent in range | Standard Error 0.679 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (1st trimester) | 8.07 percentage of time spent in range | Standard Error 1.15 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (2nd trimester) | 6.26 percentage of time spent in range | Standard Error 1.15 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (3rd trimester) | 5.05 percentage of time spent in range | Standard Error 1.15 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (Postpartum) | 5.60 percentage of time spent in range | Standard Error 1.17 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (1st Trimester) | 62.2 percentage of time spent in range | Standard Error 2.95 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (2nd Trimester) | 60.6 percentage of time spent in range | Standard Error 2.95 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (3rd Trimester) | 68.3 percentage of time spent in range | Standard Error 2.95 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (Postpartum) | 59.0 percentage of time spent in range | Standard Error 3 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (1st Trimester) | 30.9 percentage of time spent in range | Standard Error 3.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (2nd Trimester) | 34.4 percentage of time spent in range | Standard Error 3.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (3rd Trimester) | 27.8 percentage of time spent in range | Standard Error 3.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (Postpartum) | 36.5 percentage of time spent in range | Standard Error 3.33 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (1st Trimester) | 12.75 percentage of time spent in range | Standard Error 2.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (2nd Trimester) | 13.05 percentage of time spent in range | Standard Error 2.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (3rd Trimester) | 8.44 percentage of time spent in range | Standard Error 2.27 |
| Sensor-augmented Pump Therapy (SAPT) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (Postpartum) | 15.31 percentage of time spent in range | Standard Error 2.31 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (2nd Trimester) | 17.80 percentage of time spent in range | Standard Error 2.32 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (1st Trimester) | 4.04 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (3rd Trimester) | 61.8 percentage of time spent in range | Standard Error 3.02 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (2nd Trimester) | 1.68 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (Postpartum) | 45.7 percentage of time spent in range | Standard Error 3.35 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (3rd Trimester) | 1.23 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (Postpartum) | 52.7 percentage of time spent in range | Standard Error 3.02 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <54 mg/ dL (Postpartum) | 1.16 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (Postpartum) | 21.08 percentage of time spent in range | Standard Error 2.32 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (1st trimester) | 7.46 percentage of time spent in range | Standard Error 1.18 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (1st Trimester) | 31.9 percentage of time spent in range | Standard Error 3.35 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (2nd trimester) | 3.52 percentage of time spent in range | Standard Error 1.18 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (1st Trimester) | 14.62 percentage of time spent in range | Standard Error 2.32 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (3rd trimester) | 2.81 percentage of time spent in range | Standard Error 1.18 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (2nd Trimester) | 40.2 percentage of time spent in range | Standard Error 3.35 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent <63 mg/ dL (Postpartum) | 2.58 percentage of time spent in range | Standard Error 1.18 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >180 mg/ dL (3rd Trimester) | 13.75 percentage of time spent in range | Standard Error 2.32 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (1st Trimester) | 61.7 percentage of time spent in range | Standard Error 3.02 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent >140 mg/ dL (3rd Trimester) | 36.4 percentage of time spent in range | Standard Error 3.35 |
| Hybrid Closed-loop Therapy (HCL) | Indices of Glucose Control: Time Spent in Glucose Ranges by Continuous Glucose Monitoring | Time spent 63-140 mg/ dL (2nd Trimester) | 57.3 percentage of time spent in range | Standard Error 3.02 |
Primary
Number of Episodes of Severe Hypoglycemia
Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through the number of episodes of severe hypoglycemia requiring 3rd party assistance
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Number of Episodes of Severe Hypoglycemia | 0 Number of Episodes |
| Hybrid Closed-loop Therapy (HCL) | Number of Episodes of Severe Hypoglycemia | 0 Number of Episodes |
Primary
Time Spent With Glucose <54 mg/dL
Safety of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period assessed through continuous glucose monitor time spent with glucose \<54 mg/dL
Time frame: Through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (1st Trimester) | 3.98 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (2nd Trimester) | 2.84 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (3rd Trimester) | 2.01 percentage of time spent in range | Standard Error 0.668 |
| Sensor-augmented Pump Therapy (SAPT) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (Postpartum) | 2.66 percentage of time spent in range | Standard Error 0.679 |
| Hybrid Closed-loop Therapy (HCL) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (Postpartum) | 1.16 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (1st Trimester) | 4.04 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (3rd Trimester) | 1.23 percentage of time spent in range | Standard Error 0.683 |
| Hybrid Closed-loop Therapy (HCL) | Time Spent With Glucose <54 mg/dL | Time spent with glucose <54 mg/dL (2nd Trimester) | 1.68 percentage of time spent in range | Standard Error 0.683 |
Secondary
Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome
Fetal outcomes includes large-for-gestational age in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome | 6 Participants |
| Hybrid Closed-loop Therapy (HCL) | Fetal Outcomes: Number of Infants With Large-for-gestational Age Outcome | 6 Participants |
Secondary
Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth)
Fetal outcomes includes fetal loss (miscarriage or stillbirth) in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) | 0 Participants |
| Hybrid Closed-loop Therapy (HCL) | Fetal Outcomes: Number of Participants With a Fetal Loss (Miscarriage or Stillbirth) | 0 Participants |
Secondary
Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants
Fetal outcomes includes neonatal hypoglycemia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants | 4 Participants |
| Hybrid Closed-loop Therapy (HCL) | Fetal Outcomes: Number of Participants With Neonatal Hypoglycemia Infants | 5 Participants |
Secondary
Glucose Monitoring Satisfaction Survey (GMSS) Score
Device acceptability as measured by scores from the Glucose Monitoring Satisfaction Survey questionnaires of HCL compared to SAPT in pregnancy women with T1D. The GMSS has a total score and 4 subscales: openness, emotional burden, behavioral burden, and trust. Possible scores range from 1-5, with higher total scores indicating greater satisfaction. Scores are reflective of the mean of the Total or subscale questions.
Time frame: through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (1st Trimester) | 4.07 score on a scale | Standard Deviation 0.13 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (2nd Trimester) | 3.65 score on a scale | Standard Deviation 0.15 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (3rd Trimester) | 3.66 score on a scale | Standard Deviation 0.15 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (Postpartum) | 3.90 score on a scale | Standard Deviation 0.16 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (1st Trimester) | 3.99 score on a scale | Standard Deviation 0.19 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (2nd Trimester) | 3.43 score on a scale | Standard Deviation 0.22 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (3rd Trimester) | 3.75 score on a scale | Standard Deviation 0.23 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (Postpartum) | 3.76 score on a scale | Standard Deviation 0.24 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (1st Trimester) | 1.86 score on a scale | Standard Deviation 0.15 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (2nd Trimester) | 2.07 score on a scale | Standard Deviation 0.17 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (3rd Trimester) | 2.29 score on a scale | Standard Deviation 0.17 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (Postpartum) | 1.99 score on a scale | Standard Deviation 0.18 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (1st Trimester) | 1.83 score on a scale | Standard Deviation 0.19 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (2nd Trimester) | 2.41 score on a scale | Standard Deviation 0.21 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (3rd Trimester) | 2.34 score on a scale | Standard Deviation 0.22 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (Postpartum) | 2.06 score on a scale | Standard Deviation 0.23 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (1st Trimester) | 3.95 score on a scale | Standard Deviation 0.14 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (2nd Trimester) | 3.58 score on a scale | Standard Deviation 0.16 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (3rd Trimester) | 3.55 score on a scale | Standard Deviation 0.17 |
| Sensor-augmented Pump Therapy (SAPT) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (Postpartum) | 3.86 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (2nd Trimester) | 3.76 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (1st Trimester) | 3.83 score on a scale | Standard Deviation 0.13 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (3rd Trimester) | 1.99 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (2nd Trimester) | 4.06 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (Postpartum) | 2.02 score on a scale | Standard Deviation 0.23 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (3rd Trimester) | 3.89 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (Postpartum) | 1.97 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Total (Postpartum) | 3.95 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (Postpartum) | 3.97 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (1st Trimester) | 3.65 score on a scale | Standard Deviation 0.2 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (1st Trimester) | 2.11 score on a scale | Standard Deviation 0.19 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (2nd Trimester) | 4.10 score on a scale | Standard Deviation 0.24 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (1st Trimester) | 3.74 score on a scale | Standard Deviation 0.14 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (3rd Trimester) | 4.10 score on a scale | Standard Deviation 0.24 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (2nd Trimester) | 1.85 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Trust (Postpartum) | 3.77 score on a scale | Standard Deviation 0.24 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Openness (3rd Trimester) | 3.43 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (1st Trimester) | 2.01 score on a scale | Standard Deviation 0.15 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Emotional Burden (3rd Trimester) | 1.92 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Glucose Monitoring Satisfaction Survey (GMSS) Score | GMSS Behavioral Burden (2nd Trimester) | 1.78 score on a scale | Standard Deviation 0.18 |
Secondary
INSPIRE Questionnaire Score
Quality of life as measured by scores from the INSPIRE questionnaire of HCL in pregnant women with T1D. The INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a survey consisting of 22 questions that assess user expectations and experiences with automated insulin delivery systems. Scores are calculated by determining the mean of the sum of all questions then multiplying the mean by 25 for a range of 0 to 100. Higher scores indicate more positive perceptions of the system. Each survey question uses a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Time frame: through study completion, an average of 9 months
Population: INSPIRE Questionnaire only among HCL randomized group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | INSPIRE Questionnaire Score | Baseline/1st Trimester | 73.6 score on a scale | Standard Deviation 4.1 |
| Sensor-augmented Pump Therapy (SAPT) | INSPIRE Questionnaire Score | 2nd Trimester | 79.3 score on a scale | Standard Deviation 4.8 |
| Sensor-augmented Pump Therapy (SAPT) | INSPIRE Questionnaire Score | 3rd Trimester | 76.2 score on a scale | Standard Deviation 4.6 |
| Sensor-augmented Pump Therapy (SAPT) | INSPIRE Questionnaire Score | Post-Partum | 76.5 score on a scale | Standard Deviation 4.8 |
Secondary
Insulin Delivery Satisfaction Survey (IDSS) Score
Device acceptability as measured by scores from the Insulin Delivery Satisfaction Survey of HCL and SAPT arms in pregnant women with T1D. The IDSS scale has a total score and 3 subscales: effective, burdensome, and inconvenient. Possible scores range from 1-5, with higher scores indicating higher satisfaction with insulin delivery system. Scores are reflective of the mean of the Total or subscale questions.
Time frame: through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (1st Trimester) | 4.00 score on a scale | Standard Deviation 0.14 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (2nd Trimester) | 3.80 score on a scale | Standard Deviation 0.015 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (3rd Trimester) | 3.85 score on a scale | Standard Deviation 0.16 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (Postpartum) | 3.92 score on a scale | Standard Deviation 0.16 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (1st Trimester) | 4.12 score on a scale | Standard Deviation 0.15 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (2nd Trimester) | 4.13 score on a scale | Standard Deviation 0.17 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (3rd Trimester) | 4.26 score on a scale | Standard Deviation 0.17 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (Postpartum) | 4.26 score on a scale | Standard Deviation 0.18 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (1st Trimester) | 2.10 score on a scale | Standard Deviation 0.19 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (2nd Trimester) | 2.46 score on a scale | Standard Deviation 0.21 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (3rd Trimester) | 2.36 score on a scale | Standard Deviation 0.21 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (Postpartum) | 2.41 score on a scale | Standard Deviation 0.22 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (1st Trimester) | 2.03 score on a scale | Standard Deviation 0.18 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (2nd Trimester) | 2.27 score on a scale | Standard Deviation 0.2 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (3rd Trimester) | 2.36 score on a scale | Standard Deviation 0.21 |
| Sensor-augmented Pump Therapy (SAPT) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (Postpartum) | 2.07 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (Postpartum) | 1.63 score on a scale | Standard Deviation 0.21 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (1st Trimester) | 4.06 score on a scale | Standard Deviation 0.14 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (1st Trimester) | 2.08 score on a scale | Standard Deviation 0.19 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (2nd Trimester) | 4.19 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (1st Trimester) | 1.90 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (3rd Trimester) | 3.92 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (2nd Trimester) | 2.04 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Total (Postpartum) | 4.20 score on a scale | Standard Deviation 0.16 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (3rd Trimester) | 2.17 score on a scale | Standard Deviation 0.21 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (1st Trimester) | 4.16 score on a scale | Standard Deviation 0.15 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (3rd Trimester) | 2.24 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (2nd Trimester) | 4.32 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Inconvenient (2nd Trimester) | 1.69 score on a scale | Standard Deviation 0.21 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (3rd Trimester) | 4.16 score on a scale | Standard Deviation 0.18 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Burdensome (Postpartum) | 2.06 score on a scale | Standard Deviation 0.22 |
| Hybrid Closed-loop Therapy (HCL) | Insulin Delivery Satisfaction Survey (IDSS) Score | IDSS Effective (Postpartum) | 4.32 score on a scale | Standard Deviation 0.18 |
Secondary
Maternal Outcomes: Average Gestational Weight Gain
Maternal outcomes includes gestational weight gain in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Maternal Outcomes: Average Gestational Weight Gain | 14.1 kg | Standard Deviation 6 |
| Hybrid Closed-loop Therapy (HCL) | Maternal Outcomes: Average Gestational Weight Gain | 11.5 kg | Standard Deviation 4.1 |
Secondary
Maternal Outcomes: Number of Participants With Cesarean Delivery
Maternal outcomes includes cesarean delivery in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Maternal Outcomes: Number of Participants With Cesarean Delivery | 10 Participants |
| Hybrid Closed-loop Therapy (HCL) | Maternal Outcomes: Number of Participants With Cesarean Delivery | 7 Participants |
Secondary
Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia
Maternal outcomes includes preeclampsia/eclampsia in pregnant women with T1D using HCL therapy compared to those using SAPT throughout gestation and in the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia | 4 Participants |
| Hybrid Closed-loop Therapy (HCL) | Maternal Outcomes: Number of Participants With Preeclampsia/Eclampsia | 4 Participants |
Secondary
Medical Outcomes Study (MOS) Short-Form 36 Score
Quality of life as measured by scores from the MOS Short-Form 36 (quality of life) of HCL and SAPT arms in pregnant women with T1D. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Time frame: through study completion, an average of 9 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (3rd Trimester) | 76.12 score on a scale | Standard Deviation 4.22 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (2nd Trimester) | 85.94 score on a scale | Standard Deviation 5.32 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (Postpartum) | 71.42 score on a scale | Standard Deviation 4.42 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (3rd Trimester) | 66.01 score on a scale | Standard Deviation 3.92 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (1st Trimester) | 46.22 score on a scale | Standard Deviation 5.48 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (3rd Trimester) | 63.37 score on a scale | Standard Deviation 5.52 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (2nd Trimester) | 51.04 score on a scale | Standard Deviation 5.99 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (2nd Trimester) | 62.61 score on a scale | Standard Deviation 4.6 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (3rd Trimester) | 48.56 score on a scale | Standard Deviation 6.16 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (Postpartum) | 67.50 score on a scale | Standard Deviation 5.8 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (Postpartum) | 40.95 score on a scale | Standard Deviation 6.4 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (2nd Trimester) | 76.30 score on a scale | Standard Deviation 3.8 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (1st Trimester) | 81.98 score on a scale | Standard Deviation 7.33 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (1st Trimester) | 85.99 score on a scale | Standard Deviation 3.89 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (2nd Trimester) | 84.70 score on a scale | Standard Deviation 8.01 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (3rd Trimester) | 59.95 score on a scale | Standard Deviation 4.67 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (3rd Trimester) | 76.96 score on a scale | Standard Deviation 8.28 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (2nd Trimester) | 81.62 score on a scale | Standard Deviation 4.54 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (Postpartum) | 84.51 score on a scale | Standard Deviation 8.65 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (Postpartum) | 70.45 score on a scale | Standard Deviation 4.09 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (1st Trimester) | 71.70 score on a scale | Standard Deviation 8.96 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (3rd Trimester) | 82.28 score on a scale | Standard Deviation 4.74 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (2nd Trimester) | 83.72 score on a scale | Standard Deviation 10.16 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (Postpartum) | 64.70 score on a scale | Standard Deviation 4.77 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (3rd Trimester) | 42.62 score on a scale | Standard Deviation 10.45 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (Postpartum) | 82.14 score on a scale | Standard Deviation 5 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (Postpartum) | 81.83 score on a scale | Standard Deviation 10.99 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (1st Trimester) | 73.96 score on a scale | Standard Deviation 3.51 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (1st Trimester) | 88.89 score on a scale | Standard Deviation 4.22 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (1st Trimester) | 78.59 score on a scale | Standard Deviation 3.61 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (2nd Trimester) | 91.52 score on a scale | Standard Deviation 4.86 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (1st Trimester) | 81.33 score on a scale | Standard Deviation 4.68 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (3rd Trimester) | 79.65 score on a scale | Standard Deviation 5.06 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (2nd Trimester) | 70.45 score on a scale | Standard Deviation 4.07 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (Postpartum) | 84.69 score on a scale | Standard Deviation 5.32 |
| Sensor-augmented Pump Therapy (SAPT) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (1st Trimester) | 63.33 score on a scale | Standard Deviation 4.4 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (Postpartum) | 92.15 score on a scale | Standard Deviation 5.29 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (2nd Trimester) | 85.72 score on a scale | Standard Deviation 4.04 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (3rd Trimester) | 77.09 score on a scale | Standard Deviation 4.04 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (Postpartum) | 80.55 score on a scale | Standard Deviation 4.05 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (1st Trimester) | 64.05 score on a scale | Standard Deviation 4.32 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (2nd Trimester) | 67.77 score on a scale | Standard Deviation 4.69 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (3rd Trimester) | 62.72 score on a scale | Standard Deviation 4.69 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 General Health (Postpartum) | 65.45 score on a scale | Standard Deviation 4.69 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (1st Trimester) | 90.66 score on a scale | Standard Deviation 4.62 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (2nd Trimester) | 93.89 score on a scale | Standard Deviation 5.74 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (3rd Trimester) | 80.78 score on a scale | Standard Deviation 5.75 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Pain (Postpartum) | 79.64 score on a scale | Standard Deviation 5.75 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (1st Trimester) | 90.36 score on a scale | Standard Deviation 3.86 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (2nd Trimester) | 95.31 score on a scale | Standard Deviation 4.96 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (3rd Trimester) | 89.83 score on a scale | Standard Deviation 4.96 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Social Functioning (Postpartum) | 91.26 score on a scale | Standard Deviation 4.97 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (1st Trimester) | 83.18 score on a scale | Standard Deviation 3.56 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (2nd Trimester) | 84.15 score on a scale | Standard Deviation 4.37 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (3rd Trimester) | 78.72 score on a scale | Standard Deviation 4.38 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Wellbeing (Postpartum) | 84.56 score on a scale | Standard Deviation 4.38 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (1st Trimester) | 53.06 score on a scale | Standard Deviation 5.39 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (2nd Trimester) | 57.29 score on a scale | Standard Deviation 6.32 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (3rd Trimester) | 45.97 score on a scale | Standard Deviation 6.32 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Energy (Postpartum) | 53.76 score on a scale | Standard Deviation 6.33 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (1st Trimester) | 95.74 score on a scale | Standard Deviation 7.2 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (2nd Trimester) | 98.44 score on a scale | Standard Deviation 8.55 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (3rd Trimester) | 91.08 score on a scale | Standard Deviation 8.56 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Emotional Limits (Postpartum) | 98.00 score on a scale | Standard Deviation 8.57 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (1st Trimester) | 88.61 score on a scale | Standard Deviation 8.82 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (2nd Trimester) | 95.69 score on a scale | Standard Deviation 10.97 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (3rd Trimester) | 90.26 score on a scale | Standard Deviation 10.98 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Health Limits (Postpartum) | 81.83 score on a scale | Standard Deviation 10.99 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (1st Trimester) | 93.47 score on a scale | Standard Deviation 4.18 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (2nd Trimester) | 93.31 score on a scale | Standard Deviation 5.28 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Physical Functioning (3rd Trimester) | 78.97 score on a scale | Standard Deviation 5.28 |
| Hybrid Closed-loop Therapy (HCL) | Medical Outcomes Study (MOS) Short-Form 36 Score | SF36 Total (1st Trimester) | 82.23 score on a scale | Standard Deviation 3.44 |
Secondary
Number of Adverse Skin Reactions
Secondary safety assessed through the number of adverse skin reactions of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period
Time frame: through study completion, an average of 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Number of Adverse Skin Reactions | 5 Number of Reactions |
| Hybrid Closed-loop Therapy (HCL) | Number of Adverse Skin Reactions | 1 Number of Reactions |
Secondary
Number of Episodes of Diabetic Ketoacidosis
Secondary safety assessed through the number of episodes of diabetic ketoacidosis of HCL therapy compared to SAPT in women with T1D throughout gestation and the early post-partum period.
Time frame: Through study completion, an average of 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Number of Episodes of Diabetic Ketoacidosis | 0 Number of Episodes |
| Hybrid Closed-loop Therapy (HCL) | Number of Episodes of Diabetic Ketoacidosis | 1 Number of Episodes |
Secondary
Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Continuous Overall Net Glycemic Action (CONGAn) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. CONGAn assesses glycemic variability by calculating the difference between the glucose values taken at different timeframes. Lower values represent less glycemic differences between the timepoints. Higher values represent more glycemic differences between timepoints.
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (2nd Trimester) | 36.4 mg/dL | Standard Error 1.99 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (Post-Partum) | 40.0 mg/dL | Standard Error 2.03 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (3rd Trimester) | 29.6 mg/dL | Standard Error 1.99 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (Run-In Phase) | 39.9 mg/dL | Standard Error 1.99 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (1st Trimester) | 41.3 mg/dL | Standard Error 1.99 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (Run-In Phase) | 42.0 mg/dL | Standard Error 2.04 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (1st Trimester) | 44.3 mg/dL | Standard Error 2.04 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (2nd Trimester) | 40.1 mg/dL | Standard Error 2.04 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (3rd Trimester) | 35.2 mg/dL | Standard Error 2.04 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Continuous Overall Net Glycemic Action (CONGAn) | CONGAn (Post-Partum) | 42.6 mg/dL | Standard Error 2.04 |
Secondary
Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as High Blood Glucose Index (HBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. HBGI is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The range of values is 0-100 with 0 indicating no risk of high blood sugar and 100 indicating maximum possible risk of high blood sugar.
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (1st Trimester) | 5.23 score on a scale | Standard Error 0.604 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (3rd Trimester) | 3.57 score on a scale | Standard Error 0.604 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (2nd Trimester) | 4.78 score on a scale | Standard Error 0.604 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (Post-Partum) | 5.70 score on a scale | Standard Error 0.615 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (Run-In Phase) | 4.54 score on a scale | Standard Error 0.604 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (Post-Partum) | 6.42 score on a scale | Standard Error 0.618 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (Run-In Phase) | 5.32 score on a scale | Standard Error 0.618 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (1st Trimester) | 6.12 score on a scale | Standard Error 0.618 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (2nd Trimester) | 5.61 score on a scale | Standard Error 0.618 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: High Blood Glucose Index (HBGI) | HBGI (3rd Trimester) | 4.58 score on a scale | Standard Error 0.618 |
Secondary
Secondary Indices of Glucose Control: J-index
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as J index in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. J index is a measure of the quality of glycemic control. Lower values represent more glycemic control and higher values represent less glycemic control. Formula: J-Index= 0.001 x (mean blood glucose level + SD)\^2 The J-Index has not been validated in this population of Type 1 Diabetes pregnancies.
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: J-index | J-Index (1st Trimester) | 29.3 mg/dL | Standard Error 2.25 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: J-index | J-Index (3rd Trimester) | 25.1 mg/dL | Standard Error 2.25 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: J-index | J-Index (2nd Trimester) | 29.5 mg/dL | Standard Error 2.25 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: J-index | J-Index (Post-Partum) | 32.1 mg/dL | Standard Error 2.3 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: J-index | J-Index (Run-In Phase) | 26.2 mg/dL | Standard Error 2.25 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: J-index | J-Index (Post-Partum) | 38.0 mg/dL | Standard Error 2.31 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: J-index | J-Index (Run-In Phase) | 29.5 mg/dL | Standard Error 2.31 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: J-index | J-Index (1st Trimester) | 32.0 mg/dL | Standard Error 2.31 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: J-index | J-Index (2nd Trimester) | 34.6 mg/dL | Standard Error 2.31 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: J-index | J-Index (3rd Trimester) | 30.7 mg/dL | Standard Error 2.31 |
Secondary
Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Low Blood Glucose Index (LBGI) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. LBGI is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The range is from 0-100 with 0 indicating no risk of low blood sugar and 100 indicating maximum possible risk of low blood sugar.
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (1st Trimester) | 5.40 score on a scale | Standard Error 0.516 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (3rd Trimester) | 4.06 score on a scale | Standard Error 0.516 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (2nd Trimester) | 4.83 score on a scale | Standard Error 0.516 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (Post-Partum) | 4.86 score on a scale | Standard Error 0.525 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (Run-In Phase) | 5.48 score on a scale | Standard Error 0.516 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (Post-Partum) | 3.69 score on a scale | Standard Error 0.528 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (Run-In Phase) | 5.67 score on a scale | Standard Error 0.528 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (1st Trimester) | 5.92 score on a scale | Standard Error 0.528 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (2nd Trimester) | 4.09 score on a scale | Standard Error 0.528 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Low Blood Glucose Index (LBGI) | LBGI (3rd Trimester) | 3.44 score on a scale | Standard Error 0.528 |
Secondary
Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE)
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as Mean Amplitude of Glycemic Excursions (MAGE) in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum. MAGE is the average difference between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of the average value of glucose in a given day. Lower values represent less glycemic variability on average. Higher values represent more glycemic variability on average.
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (1st Trimester) | 91.9 mg/dL | Standard Error 5.47 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (3rd Trimester) | 69.2 mg/dL | Standard Error 5.47 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (2nd Trimester) | 85.4 mg/dL | Standard Error 5.47 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (Post-Partum) | 92.9 mg/dL | Standard Error 5.59 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (Run-In Phase) | 84.4 mg/dL | Standard Error 5.47 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (Post-Partum) | 99.5 mg/dL | Standard Error 5.61 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (Run-In Phase) | 98.8 mg/dL | Standard Error 5.61 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (1st Trimester) | 100.9 mg/dL | Standard Error 5.61 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (2nd Trimester) | 94.5 mg/dL | Standard Error 5.61 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Amplitude of Glycemic Excursions (MAGE) | MAGE (3rd Trimester) | 81.8 mg/dL | Standard Error 5.61 |
Secondary
Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation
Secondary outcomes of indices of glycemic variability by continuous glucose monitoring as mean glucose ± standard deviation in pregnant women with T1D using HCL or SAPT therapy throughout pregnancy and early post-partum
Time frame: through study completion, an average of 9 months
Population: The HCL group had 11 participants complete the study after randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 1st Trimester | 122 mg/dL | Standard Deviation 4 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 3rd Trimester | 120 mg/dL | Standard Deviation 4 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 2nd Trimester | 126 mg/dL | Standard Deviation 4 |
| Sensor-augmented Pump Therapy (SAPT) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | Postpartum | 130 mg/dL | Standard Deviation 4 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | Postpartum | 144 mg/dL | Standard Deviation 4 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 1st Trimester | 125 mg/dL | Standard Deviation 4 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 2nd Trimester | 137 mg/dL | Standard Deviation 4 |
| Hybrid Closed-loop Therapy (HCL) | Secondary Indices of Glucose Control: Mean Glucose ± Standard Deviation | 3rd Trimester | 132 mg/dL | Standard Deviation 4 |