Diabetes Mellitus, Type I
Conditions
Brief summary
A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities during pregnancy associated with T1DM.
Detailed description
A single-center, prospective, 'open-label,' investigator-initiated pilot study evaluating the role of continuous glucose monitor (CGM) use either alone or with remote monitoring capabilities that enable subjects to share CGM data with family and friends (whom the investigators will call followers in this protocol) among women with T1DM associated with pregnancy.
Interventions
DEVICEDexcom G4 or G5 Platinum CGM system
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
DEVICEDexcom G4 or G5 Platinum CGM system with Share
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
Sponsors
DexCom, Inc.
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent before any study-related activities * Female aged 18 years and older * T1D duration \>1 year * Pregnancy with confirmation of gestational age 13 weeks or less * Willingness to routinely practice at least 3-7 blood glucose measurements per day * Using MDI or CSII therapy * Willingness to provide an A1C level * Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy * Able to speak, read, and write English
Exclusion criteria
* Extensive skin changes/diseases that inhibit wearing a sensor on normal skin * Known allergy to adhesives * Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glucose Variability | From first pregnancy visit to delivery | Glucose variability as measured by glucose excursions from CGM |
| Change(s) in Behavior and/or Concerns of Diabetics. | From first pregnancy visit to delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C. | From first pregnancy visit to delivery | Change in A1C with CGM alone and CGM with Share™ compared to no CGM use. |
| Evaluation of Maternal and Fetal Outcomes. | From first pregnancy visit to delivery | Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures) |
Countries
United States
Participant flow
Recruitment details
From 08/2015 to 06/2016, investigators enrolled women in preconception and the 1st trimester at the Barbara Davis Center, and followers. Other women consented for the retrospective (no CGM) group. Follower data only included answers to monthly questionnaires. Study registration was delayed due to staffing issues and account set-up in the system.
Pre-assignment details
Study cohorts: (1) women with T1D prospectively enrolled in 1st trimester or when planning pregnancy, (2) followers (family/friends) of women in the 1st cohort, and (3) women with T1D with a pregnancy within the past 3 years who did not use CGM therapy during gestation (retrospective). Follower data only included answers to monthly questionnaires.
Participants by arm
| Arm | Count |
|---|---|
| Routine Care Standard of Care in the Pregnancy and Women's Health clinic. | 8 |
| Dexcom G4 Platinum CGM System An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system: Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy | 13 |
| Dexcom G4 Platinum CGM System With Share™ A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share: Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ | 15 |
| Total | 36 |
Baseline characteristics
| Characteristic | Routine Care | Dexcom G4 Platinum CGM System | Dexcom G4 Platinum CGM System With Share™ | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 13 Participants | 15 Participants | 36 Participants |
| Age, Continuous | 27.6 years | 24.4 years | 28.9 years | 27.3 years |
| Method of insulin delivery, n (%) Continuous subcutaneous insulin infusion (CSII) | 3 Participants | 6 Participants | 13 Participants | 22 Participants |
| Method of insulin delivery, n (%) Multiple daily injections (MDI) | 4 Participants | 7 Participants | 2 Participants | 13 Participants |
| Method of insulin delivery, n (%) Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Preconception hemoglobin A1C (%) | 7.2 % | 8.1 % | 7.1 % | 7.4 % |
| Race/Ethnicity, Customized Race/ethnicity Asian/Oriental | — | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Caucasian | — | 8 Participants | 14 Participants | 22 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic/Latina | — | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | — | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 8 participants | 13 participants | 15 participants | 36 participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 15 | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 3 / 13 | 4 / 15 | 0 / 12 | 0 / 14 |
Outcome results
Primary
Change(s) in Behavior and/or Concerns of Diabetics.
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.
Time frame: From first pregnancy visit to delivery
Population: Hypoglycemia Fear Survey results (higher scores indicate more behavioral changes, worry, or total fear scores). Only prospectively enrolled pregnant women were administered this questionnaire (CGM Alone and CGM Share groups).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (1st Trimester) | 45.1 score on a scale | Standard Deviation 14.8 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (2nd Trimester) | 65.8 score on a scale | Standard Deviation 15.4 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (2nd trimester) | 28.2 score on a scale | Standard Deviation 6.9 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (3rd trimester) | 28.6 score on a scale | Standard Deviation 6.6 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (1st Trimester) | 73.8 score on a scale | Standard Deviation 14.1 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (3rd Trimester) | 43.4 score on a scale | Standard Deviation 19 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (2nd Trimester) | 37.5 score on a scale | Standard Deviation 12.5 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (3rd Trimester) | 72.0 score on a scale | Standard Deviation 23.8 |
| Dexcom G4 Platinum CGM System | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (1st trimester) | 28.8 score on a scale | Standard Deviation 5.8 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (3rd Trimester) | 65.5 score on a scale | Standard Deviation 10.7 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (1st trimester) | 27.9 score on a scale | Standard Deviation 3.9 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (1st Trimester) | 34.0 score on a scale | Standard Deviation 7.2 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (1st Trimester) | 61.9 score on a scale | Standard Deviation 9.4 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (2nd trimester) | 28.9 score on a scale | Standard Deviation 4.5 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (2nd Trimester) | 34.6 score on a scale | Standard Deviation 9.7 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Total Score (2nd Trimester) | 63.4 score on a scale | Standard Deviation 13 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Behavior score (3rd trimester) | 28.2 score on a scale | Standard Deviation 4.1 |
| Dexcom G4 Platinum CGM System With Share™ | Change(s) in Behavior and/or Concerns of Diabetics. | Worry Score (3rd Trimester) | 37.4 score on a scale | Standard Deviation 7.8 |
Primary
Changes in Glucose Variability
Glucose variability as measured by glucose excursions from CGM
Time frame: From first pregnancy visit to delivery
Population: CGM metrics among CGM Share and CGM Alone (not among no CGM since they did not use a CGM)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent 65-140 mg/dL (1st trimester) | 52.8 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent >140 mg/dL (2nd trimester) | 44.2 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent <65 mg/dL (2nd trimester) | 5.0 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent <65 mg/dL (3rd trimester) | 4.0 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent >140 mg/dL (1st trimester) | 38.2 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent 65-140 mg/dL (3rd trimester) | 53.5 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent 65-140 mg/dL (2nd trimester) | 50.7 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent >140 mg/dL (3rd trimester) | 43.2 % time spent in range |
| Dexcom G4 Platinum CGM System | Changes in Glucose Variability | Time spent <65 mg/dL (1st trimester) | 7.5 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent >140 mg/dL (3rd trimester) | 34.4 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent <65 mg/dL (1st trimester) | 7.3 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent 65-140 mg/dL (1st trimester) | 59.8 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent >140 mg/dL (1st trimester) | 35.1 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent <65 mg/dL (2nd trimester) | 5.3 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent 65-140 mg/dL (2nd trimester) | 56.6 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent >140 mg/dL (2nd trimester) | 37.2 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent <65 mg/dL (3rd trimester) | 4.5 % time spent in range |
| Dexcom G4 Platinum CGM System With Share™ | Changes in Glucose Variability | Time spent 65-140 mg/dL (3rd trimester) | 62.3 % time spent in range |
Secondary
Change in A1C.
Change in A1C with CGM alone and CGM with Share™ compared to no CGM use.
Time frame: From first pregnancy visit to delivery
Population: Least squares mean HbA1c by group in a model without interaction and without adjustment for preconception HbA1c.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dexcom G4 Platinum CGM System | Change in A1C. | 6.85 HbA1C % | Standard Error 0.13 |
| Dexcom G4 Platinum CGM System With Share™ | Change in A1C. | 6.84 HbA1C % | Standard Error 0.09 |
| Dexcom G4 Platinum CGM System With Share™ | Change in A1C. | 6.19 HbA1C % | Standard Error 0.07 |
Secondary
Evaluation of Maternal and Fetal Outcomes.
Evaluation of Maternal and fetal outcomes (eclampsia/pre-eclampsia, live birth rates, birth weight, neonatal hypoglycemia, and other similar measures)
Time frame: From first pregnancy visit to delivery
Population: Maternal and fetal outcomes among prospective pregnant study arms (CGM Share and CGM Alone)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | <37 weeks gestation at delivery, n (%) | 7 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Neonatal jaundice, n (%) | 8 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Macrosomia, n (%) | 0 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Neonatal hypoxemia, n (%) | 6 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Preeclampsia, n (%) | 4 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Neonatal intensive care unit admission, n (%) | 5 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Small-for-gestational age infant, n (%) | 0 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retinopathy (both eyes) | 2 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Large-for-gestational age infant, n (%) | 5 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retionpathy (one eye) | 3 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Neonatal hypoglycemia, n (%) | 7 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retinopathy (neither eye) | 5 Participants |
| Dexcom G4 Platinum CGM System | Evaluation of Maternal and Fetal Outcomes. | Cesarean section, n (%) | 8 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retinopathy (neither eye) | 4 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Cesarean section, n (%) | 13 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Preeclampsia, n (%) | 4 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | <37 weeks gestation at delivery, n (%) | 4 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Large-for-gestational age infant, n (%) | 8 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Macrosomia, n (%) | 3 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Small-for-gestational age infant, n (%) | 1 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Neonatal hypoglycemia, n (%) | 11 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Neonatal jaundice, n (%) | 5 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Neonatal hypoxemia, n (%) | 1 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Neonatal intensive care unit admission, n (%) | 7 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retinopathy (both eyes) | 2 Participants |
| Dexcom G4 Platinum CGM System With Share™ | Evaluation of Maternal and Fetal Outcomes. | Progression of diabetic retionpathy (one eye) | 2 Participants |