Type 1 Diabetes Mellitus
Conditions
Keywords
T1D, Omnipod
Brief summary
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Detailed description
The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting. The hybrid closed-loop phase will begin on Study Day 1. During the hybrid closed-loop phase, subjects will be divided into two groups. The first group of subjects will commence the hybrid closed-loop phase in the hotel/rental house setting. On Study Day 3, subjects will transition to an outpatient setting for the remaining 12 days. After all subjects from the first group have completed the 2-day hotel/rental house phase, the second group of subjects may commence the hybrid closed-loop phase in an outpatient setting for 14-days. During the hybrid closed-loop phase, all subjects will participate in specific target blood glucose (BG) challenges. After each subject in the prepivotal study has successfully completed 14-days of hybrid-closed-loop, they may immediately transition to and enroll in the pivotal study.
Interventions
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
Sponsors
Insulet Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm, multi-center, prospective clinical study.
Eligibility
Sex/Gender
ALL
Age
6 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent/assent 6-70 years 2. Subjects aged \< 18 years must be living with parent/legal guardian 3. Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment. 4. Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities 5. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol 6. Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog, or Apidra during the study 7. Must be willing to set target glucose between 130-150 mg/dL each for approximately 72-hours on predefined days during the hybrid closed-loop phase 8. Must be willing to extend their participation into the pivotal study if they continue to meet the protocol criteria 9. Willing to wear the system continuously throughout the study 10. A1C \<10% at screening visit 11. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase 12. Subjects scoring ≥ 4 on the Clarke Questionnaire must agree to have an overnight companion, defined as someone who resides in the same home or building as the study subject and who can be available overnight 13. Able to read and speak English fluently 14. Subject must be in an AT&T covered area 15. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from pediatric and adolescent subjects aged \< 18 years per State requirements.
Exclusion criteria
1. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk 2. History of severe hypoglycemia (as defined in Section 11.3.3) in the past 6 months 3. History of DKA (as defined in Section 11.3.4) in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis 4. Diagnosed with sickle cell disease 5. Diagnosed with hemophilia or any other bleeding disorders 6. Plans to receive blood transfusion over the course of the study 7. Currently diagnosed with anorexia nervosa or bulimia 8. Acute or chronic kidney disease (e.g. estimated GFR \< 45) or currently on hemodialysis 9. History of adrenal insufficiency 10. Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the course of the study 11. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 12. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study 13. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 14. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months. 15. For subjects \>50 years old or with diabetes duration \>20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (\> 450 ms) 16. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism 17. Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant) 18. Participation in another clinical study using an investigational drug or device within the preceding 30-days or intends to participate during the study period 19. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Severe Hypoglycemia | hybrid closed-loop (14 days) | Measure of serious device-related adverse events |
| Proportion of Subjects With Diabetic Ketoacidosis (DKA) | hybrid closed-loop (14 days) | Measure of serious device-related adverse events |
| Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | hybrid closed-loop (9 days) compared to standard therapy (14 days) | Percentage of time in range 70-180 mg/dL |
| Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | hybrid closed-loop (5 days) compared to standard therapy (14 days) | Percentage of time in range 70-180 mg/dL |
| Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | hybrid closed-loop (14 days) compared to standard therapy (14 days) | Percentage of time in range 70-180 mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time ≥250 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percentage of Time ≥300 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percentage of Time <70 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percentage of Time <54 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Standard Deviation of Glucose (mg/dL) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) |
| Total Daily Bolus Insulin (Units, Units/kg) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | Measure of insulin requirements |
| Glucose Management Indicator (GMI) Based on Overall Mean Glucose | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | Measurement of glucose management using overall glucose averages |
| Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | hybrid closed-loop (14 days) | Measure of system usage |
| Total Daily Insulin (TDI) (Units, Units/kg) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Basal Insulin (Units, Units/kg) | hybrid closed-loop (14 days) compared to the standard therapy (14 days) | Measure of insulin requirements |
| Coefficient of Variation | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) |
| Mean Glucose | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Time in Range 70-180 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Time in Range 70-140 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percentage of Time >180 mg/dL | hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm
Omnipod Horizon™ Automated Glucose Control System: The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 14.7 |
| BMI | 22.6 kg/m^2 STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 4 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Time frame: hybrid closed-loop (5 days) compared to standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Day Time ST | 58.0 Overall Percent Time in Range | Standard Deviation 17.1 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Day Time HCL | 67.2 Overall Percent Time in Range | Standard Deviation 11.9 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Night Time ST | 59.2 Overall Percent Time in Range | Standard Deviation 16.4 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Night Time HCL | 72.8 Overall Percent Time in Range | Standard Deviation 18.2 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Overall ST | 58.3 Overall Percent Time in Range | Standard Deviation 16.2 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) | Overall HCL | 68.7 Overall Percent Time in Range | Standard Deviation 11.3 |
Primary
Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Time frame: hybrid closed-loop (14 days) compared to standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Day Time ST | 58.0 Overall Percent Time in Range | Standard Deviation 17.1 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Day Time HCL | 63.9 Overall Percent Time in Range | Standard Deviation 8.3 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Night Time ST | 59.2 Overall Percent Time in Range | Standard Deviation 16.4 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Night Time HCL | 71.1 Overall Percent Time in Range | Standard Deviation 13.3 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Overall ST | 58.3 Overall Percent Time in Range | Standard Deviation 16.2 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) | Overall HCL | 65.8 Overall Percent Time in Range | Standard Deviation 7.3 |
Primary
Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days)
Percentage of time in range 70-180 mg/dL
Time frame: hybrid closed-loop (9 days) compared to standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Day Time ST | 58 Overall Percent Time in Range | Standard Deviation 17.1 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Day Time HCL | 62.2 Overall Percent Time in Range | Standard Deviation 9.6 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Night Time ST | 59.2 Overall Percent Time in Range | Standard Deviation 16.4 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Night Time HCL | 71.2 Overall Percent Time in Range | Standard Deviation 14 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Overall ST | 58.3 Overall Percent Time in Range | Standard Deviation 16.2 |
| Treatment | Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) | Overall HCL | 64.4 Overall Percent Time in Range | Standard Deviation 8.2 |
Primary
Proportion of Subjects With Diabetic Ketoacidosis (DKA)
Measure of serious device-related adverse events
Time frame: hybrid closed-loop (14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Proportion of Subjects With Diabetic Ketoacidosis (DKA) | 0 Participants |
Primary
Proportion of Subjects With Severe Hypoglycemia
Measure of serious device-related adverse events
Time frame: hybrid closed-loop (14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Proportion of Subjects With Severe Hypoglycemia | 0 Participants |
Secondary
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Coefficient of Variation | Day Time ST | 36.3 Percent | Standard Deviation 5 |
| Treatment | Coefficient of Variation | Day Time HCL | 31.6 Percent | Standard Deviation 4.4 |
| Treatment | Coefficient of Variation | Night Time ST | 36.5 Percent | Standard Deviation 9.2 |
| Treatment | Coefficient of Variation | Night Time HCL | 27.3 Percent | Standard Deviation 7.2 |
| Treatment | Coefficient of Variation | Overall ST | 36.9 Percent | Standard Deviation 5.9 |
| Treatment | Coefficient of Variation | Overall HCL | 31.2 Percent | Standard Deviation 4.6 |
Secondary
Glucose Management Indicator (GMI) Based on Overall Mean Glucose
Measurement of glucose management using overall glucose averages
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Day Time ST | 7.4 Percent | Standard Deviation 0.7 |
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Day Time HCL | 7.3 Percent | Standard Deviation 0.3 |
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Night Time ST | 7.3 Percent | Standard Deviation 0.7 |
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Night Time HCL | 7.2 Percent | Standard Deviation 0.4 |
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Overall ST | 7.4 Percent | Standard Deviation 0.7 |
| Treatment | Glucose Management Indicator (GMI) Based on Overall Mean Glucose | Overall HCL | 7.3 Percent | Standard Deviation 0.3 |
Secondary
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Mean Glucose | Day Time ST | 172.8 mg/dL | Standard Deviation 29.8 |
| Treatment | Mean Glucose | Day Time HCL | 168.4 mg/dL | Standard Deviation 12.7 |
| Treatment | Mean Glucose | Night Time ST | 165.8 mg/dL | Standard Deviation 28.4 |
| Treatment | Mean Glucose | Night Time HCL | 163.0 mg/dL | Standard Deviation 16.2 |
| Treatment | Mean Glucose | Overall ST | 171.2 mg/dL | Standard Deviation 27.7 |
| Treatment | Mean Glucose | Overall HCL | 167.0 mg/dL | Standard Deviation 11.5 |
Secondary
Percentage of Time >180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time >180 mg/dL | Day Time ST | 39.5 Percent Time in Range | Standard Deviation 18.4 |
| Treatment | Percentage of Time >180 mg/dL | Day Time HCL | 35.1 Percent Time in Range | Standard Deviation 8.5 |
| Treatment | Percentage of Time >180 mg/dL | Night Time ST | 36.6 Percent Time in Range | Standard Deviation 17.7 |
| Treatment | Percentage of Time >180 mg/dL | Night Time HCL | 27.8 Percent Time in Range | Standard Deviation 13.4 |
| Treatment | Percentage of Time >180 mg/dL | Overall ST | 38.8 Percent Time in Range | Standard Deviation 17.2 |
| Treatment | Percentage of Time >180 mg/dL | Overall HCL | 33.3 Percent Time in Range | Standard Deviation 7.6 |
Secondary
Percentage of Time ≥250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time ≥250 mg/dL | Day Time ST | 14.6 Percent Time in Range | Standard Deviation 10.7 |
| Treatment | Percentage of Time ≥250 mg/dL | Day Time HCL | 9.1 Percent Time in Range | Standard Deviation 6.1 |
| Treatment | Percentage of Time ≥250 mg/dL | Night Time ST | 12.6 Percent Time in Range | Standard Deviation 10.5 |
| Treatment | Percentage of Time ≥250 mg/dL | Night Time HCL | 6.5 Percent Time in Range | Standard Deviation 6.6 |
| Treatment | Percentage of Time ≥250 mg/dL | Overall ST | 14.1 Percent Time in Range | Standard Deviation 9.9 |
| Treatment | Percentage of Time ≥250 mg/dL | Overall HCL | 8.5 Percent Time in Range | Standard Deviation 5.4 |
Secondary
Percentage of Time ≥300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time ≥300 mg/dL | Day Time ST | 5.6 Percent Time in Range | Standard Deviation 5.9 |
| Treatment | Percentage of Time ≥300 mg/dL | Day Time HCL | 2.4 Percent Time in Range | Standard Deviation 2.4 |
| Treatment | Percentage of Time ≥300 mg/dL | Night Time ST | 4.6 Percent Time in Range | Standard Deviation 5.8 |
| Treatment | Percentage of Time ≥300 mg/dL | Night Time HCL | 2.0 Percent Time in Range | Standard Deviation 3.2 |
| Treatment | Percentage of Time ≥300 mg/dL | Overall ST | 5.4 Percent Time in Range | Standard Deviation 5.3 |
| Treatment | Percentage of Time ≥300 mg/dL | Overall HCL | 2.3 Percent Time in Range | Standard Deviation 2.2 |
Secondary
Percentage of Time <54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time <54 mg/dL | Day Time ST | 0.5 Percent Time in Range | Standard Deviation 0.7 |
| Treatment | Percentage of Time <54 mg/dL | Day Time HCL | 0.1 Percent Time in Range | Standard Deviation 0.3 |
| Treatment | Percentage of Time <54 mg/dL | Night Time ST | 1.1 Percent Time in Range | Standard Deviation 1.8 |
| Treatment | Percentage of Time <54 mg/dL | Night Time HCL | 0.1 Percent Time in Range | Standard Deviation 0.4 |
| Treatment | Percentage of Time <54 mg/dL | Overall ST | 0.6 Percent Time in Range | Standard Deviation 0.9 |
| Treatment | Percentage of Time <54 mg/dL | Overall HCL | 0.1 Percent Time in Range | Standard Deviation 0.3 |
Secondary
Percentage of Time <70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time <70 mg/dL | Day Time ST | 2.4 Percent Time in Range | Standard Deviation 2.6 |
| Treatment | Percentage of Time <70 mg/dL | Day Time HCL | 1.0 Percent Time in Range | Standard Deviation 1.1 |
| Treatment | Percentage of Time <70 mg/dL | Night Time ST | 4.2 Percent Time in Range | Standard Deviation 5.2 |
| Treatment | Percentage of Time <70 mg/dL | Night Time HCL | 0.5 Percent Time in Range | Standard Deviation 1.3 |
| Treatment | Percentage of Time <70 mg/dL | Overall ST | 2.9 Percent Time in Range | Standard Deviation 3 |
| Treatment | Percentage of Time <70 mg/dL | Overall HCL | 0.9 Percent Time in Range | Standard Deviation 1.1 |
Secondary
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage
Time frame: hybrid closed-loop (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Automated Mode | 97.3 Percent Time Spent | Standard Deviation 3 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Manual Mode | 2.1 Percent Time Spent | Standard Deviation 2.2 |
Secondary
Standard Deviation of Glucose (mg/dL)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Standard Deviation of Glucose (mg/dL) | Day Time ST | 62.9 mg/dL | Standard Deviation 14.7 |
| Treatment | Standard Deviation of Glucose (mg/dL) | Day Time HCL | 53.4 mg/dL | Standard Deviation 9.5 |
| Treatment | Standard Deviation of Glucose (mg/dL) | Night Time ST | 60.5 mg/dL | Standard Deviation 17.8 |
| Treatment | Standard Deviation of Glucose (mg/dL) | Night Time HCL | 45.0 mg/dL | Standard Deviation 14.2 |
| Treatment | Standard Deviation of Glucose (mg/dL) | Overall ST | 63.3 mg/dL | Standard Deviation 14.9 |
| Treatment | Standard Deviation of Glucose (mg/dL) | Overall HCL | 52.3 mg/dL | Standard Deviation 9.4 |
Secondary
Time in Range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Time in Range 70-140 mg/dL | Overall ST | 36.2 Percent Time in Range | Standard Deviation 15.2 |
| Treatment | Time in Range 70-140 mg/dL | Night Time HCL | 35.3 Percent Time in Range | Standard Deviation 12.8 |
| Treatment | Time in Range 70-140 mg/dL | Day Time ST | 35.7 Percent Time in Range | Standard Deviation 15.6 |
| Treatment | Time in Range 70-140 mg/dL | Day Time HCL | 33.2 Percent Time in Range | Standard Deviation 6.7 |
| Treatment | Time in Range 70-140 mg/dL | Night Time ST | 37.8 Percent Time in Range | Standard Deviation 16.7 |
| Treatment | Time in Range 70-140 mg/dL | Overall HCL | 33.8 Percent Time in Range | Standard Deviation 6.9 |
Secondary
Time in Range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Time in Range 70-180 mg/dL | Day Time ST | 58.0 Percent Time in Range | Standard Deviation 17.1 |
| Treatment | Time in Range 70-180 mg/dL | Day Time HCL | 63.9 Percent Time in Range | Standard Deviation 8.3 |
| Treatment | Time in Range 70-180 mg/dL | Night Time ST | 59.2 Percent Time in Range | Standard Deviation 16.4 |
| Treatment | Time in Range 70-180 mg/dL | Night Time HCL | 71.1 Percent Time in Range | Standard Deviation 13.3 |
| Treatment | Time in Range 70-180 mg/dL | Overall ST | 58.3 Percent Time in Range | Standard Deviation 16.2 |
| Treatment | Time in Range 70-180 mg/dL | Overall HCL | 65.8 Percent Time in Range | Standard Deviation 7.3 |
Secondary
Total Daily Basal Insulin (Units, Units/kg)
Measure of insulin requirements
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Basal Insulin (Units, Units/kg) | ST | 20.7 units/kg | Standard Deviation 10.3 |
| Treatment | Total Daily Basal Insulin (Units, Units/kg) | HCL | 17.5 units/kg | Standard Deviation 7.6 |
Secondary
Total Daily Bolus Insulin (Units, Units/kg)
Measure of insulin requirements
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Bolus Insulin (Units, Units/kg) | ST | 19.4 units/kg | Standard Deviation 8.5 |
| Treatment | Total Daily Bolus Insulin (Units, Units/kg) | HCL | 19.5 units/kg | Standard Deviation 7.8 |
Secondary
Total Daily Insulin (TDI) (Units, Units/kg)
Measure of insulin requirements
Time frame: hybrid closed-loop (14 days) compared to the standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Insulin (TDI) (Units, Units/kg) | ST | 39.5 units/kg | Standard Deviation 13.5 |
| Treatment | Total Daily Insulin (TDI) (Units, Units/kg) | HCL | 37.0 units/kg | Standard Deviation 14.5 |