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 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 12-month extension phase.
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 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months. During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges. The hybrid closed-loop phase will begin on Study Day 1.
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
single-arm, multi-center, prospective clinical study
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent 2.0-5.9 years 2. Living with parent/legal guardian 3. Diagnosed with type 1 diabetes. 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 and/or parent/guardian/caregiver 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. Willing to wear the system continuously throughout the study 8. Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50% 9. A1C \<10% at screening visit 10. Subject and/or parent/guardian 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 11. Subject and/or parent/guardian is able to read and speak English fluently 12. Has a parent/legal guardian willing and able to sign the ICF.
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 in the past 6 months 3. History of DKA 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. Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR \< 45) or currently on hemodialysis 8. History of adrenal insufficiency 9. 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 10. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 11. Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study 12. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 13. Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism 14. Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period 15. 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 |
|---|---|---|
| Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | Number of severe hypoglycemia events reported in events per person months units. |
| Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) | Number of DKA events reported in events per person months units. |
| Glycated Hemoglobin (A1C) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline | Measures device effectiveness |
| Time in Range 70-180 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) | Measures device effectiveness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Time ≥ 300 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time < 70 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time < 54 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Mean Glucose | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Standard Deviation | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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) |
| Coefficient of Variation | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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) |
| Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days) | Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod). |
| Glycated Hemoglobin (A1C) | Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline | Measures device effectiveness |
| Total Daily Insulin (TDI) (Units) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Insulin (TDI) (Units/kg) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Basal Insulin (Units) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Basal Insulin (Units/kg) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Bolus Insulin (Units) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Total Daily Bolus Insulin (Units/kg) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Body Mass Index (BMI) (kg/m^2) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline | Measure of change in weight |
| Glucose Management Indicator (GMI) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days) | Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more. |
| Percent of Time in Range 70-140 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time > 180 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time ≥ 250 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 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. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 4.7 years STANDARD_DEVIATION 1 |
| BMI | 16.7 kg/m^2 STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 72 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 51 / 80 |
| serious Total, serious adverse events | 4 / 80 |
Outcome results
Primary
Glycated Hemoglobin (A1C)
Measures device effectiveness
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glycated Hemoglobin (A1C) | V16 | 7.0 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V19 | 7.1 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V21 | 6.9 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V23 | 7.0 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V13 | 6.9 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | Baseline | 7.4 percent A1C | Standard Deviation 1 |
Primary
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Number of DKA events reported in events per person months units.
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Phase 2 | 0 events per person months |
| Treatment | Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Phase 3 | 0.0007 events per person months |
Primary
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Number of severe hypoglycemia events reported in events per person months units.
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Phase 2 | 0 events per person months |
| Treatment | Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Phase 3 | 0.0007 events per person months |
Primary
Time in Range 70-180 mg/dL
Measures device effectiveness
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Time in Range 70-180 mg/dL | Day Time ST | 56.9 percent time in range | Standard Deviation 15.2 |
| Treatment | Time in Range 70-180 mg/dL | Day Time Phase 2 | 63.7 percent time in range | Standard Deviation 9.7 |
| Treatment | Time in Range 70-180 mg/dL | Day Time Phase 3 | 63.5 percent time in range | Standard Deviation 9.8 |
| Treatment | Time in Range 70-180 mg/dL | Night Time ST | 58.2 percent time in range | Standard Deviation 18.7 |
| Treatment | Time in Range 70-180 mg/dL | Night Time Phase 2 | 81.0 percent time in range | Standard Deviation 10 |
| Treatment | Time in Range 70-180 mg/dL | Night Time Phase 3 | 78.2 percent time in range | Standard Deviation 10.4 |
| Treatment | Time in Range 70-180 mg/dL | Overall ST | 57.2 percent time in range | Standard Deviation 15.3 |
| Treatment | Time in Range 70-180 mg/dL | Overall Phase 2 | 68.1 percent time in range | Standard Deviation 9 |
| Treatment | Time in Range 70-180 mg/dL | Overall Phase 3 | 67.2 percent time in range | Standard Deviation 9.3 |
Secondary
Body Mass Index (BMI) (kg/m^2)
Measure of change in weight
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Body Mass Index (BMI) (kg/m^2) | Baseline | 16.7 kg/m^2 | Standard Deviation 1.5 |
| Treatment | Body Mass Index (BMI) (kg/m^2) | V13 | 16.7 kg/m^2 | Standard Deviation 1.4 |
| Treatment | Body Mass Index (BMI) (kg/m^2) | V23 | 16.9 kg/m^2 | Standard Deviation 2.3 |
Secondary
Coefficient of Variation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Coefficient of Variation | Day Time ST | 38.6 percent coefficient of variation | Standard Deviation 5.7 |
| Treatment | Coefficient of Variation | Day Time Phase 2 | 38.0 percent coefficient of variation | Standard Deviation 3.8 |
| Treatment | Coefficient of Variation | Day Time Phase 3 | 38.6 percent coefficient of variation | Standard Deviation 3.7 |
| Treatment | Coefficient of Variation | Night Time ST | 34.7 percent coefficient of variation | Standard Deviation 6.6 |
| Treatment | Coefficient of Variation | Night Time Phase 2 | 32.1 percent coefficient of variation | Standard Deviation 5.2 |
| Treatment | Coefficient of Variation | Night Time Phase 3 | 33.2 percent coefficient of variation | Standard Deviation 5.1 |
| Treatment | Coefficient of Variation | Overall ST | 38.1 percent coefficient of variation | Standard Deviation 5.5 |
| Treatment | Coefficient of Variation | Overall Phase 2 | 37.7 percent coefficient of variation | Standard Deviation 4 |
| Treatment | Coefficient of Variation | Overall Phase 3 | 38.1 percent coefficient of variation | Standard Deviation 3.9 |
Secondary
Glucose Management Indicator (GMI)
Glucose Management Indicator (%) approximates the laboratory hemoglobin A1c (%) expected based on average glucose readings from continuous glucose monitors from the last 14 days or more.
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glucose Management Indicator (GMI) | Night Time ST | 7.33 percent of gmi | Standard Deviation 0.8 |
| Treatment | Glucose Management Indicator (GMI) | Night Time Phase 2 | 6.68 percent of gmi | Standard Deviation 0.39 |
| Treatment | Glucose Management Indicator (GMI) | Night Time Phase 3 | 6.79 percent of gmi | Standard Deviation 0.4 |
| Treatment | Glucose Management Indicator (GMI) | Overall ST | 7.40 percent of gmi | Standard Deviation 0.73 |
| Treatment | Glucose Management Indicator (GMI) | Overall Phase 2 | 7.08 percent of gmi | Standard Deviation 0.4 |
| Treatment | Glucose Management Indicator (GMI) | Day Time ST | 7.43 percent of gmi | Standard Deviation 0.75 |
| Treatment | Glucose Management Indicator (GMI) | Day Time Phase 2 | 7.21 percent of gmi | Standard Deviation 0.44 |
| Treatment | Glucose Management Indicator (GMI) | Day Time Phase 3 | 7.22 percent of gmi | Standard Deviation 0.46 |
| Treatment | Glucose Management Indicator (GMI) | Overall Phase 3 | 7.12 percent of gmi | Standard Deviation 0.43 |
Secondary
Glycated Hemoglobin (A1C)
Measures device effectiveness
Time frame: Hybrid closed-loop (94 days, 180 days, 270 days, and 450 days) compared to baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glycated Hemoglobin (A1C) | Baseline | 7.4 percent A1C | Standard Deviation 1 |
| Treatment | Glycated Hemoglobin (A1C) | V13 | 6.9 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V16 | 7.0 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V19 | 7.1 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V21 | 6.9 percent A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | V23 | 7.0 percent A1C | Standard Deviation 0.7 |
Secondary
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Mean Glucose | Day Time ST | 172.2 mg/dL | Standard Deviation 31.3 |
| Treatment | Mean Glucose | Day Time Phase 2 | 163.0 mg/dL | Standard Deviation 18.3 |
| Treatment | Mean Glucose | Day Time Phase 3 | 163.6 mg/dL | Standard Deviation 19.3 |
| Treatment | Mean Glucose | Night Time ST | 168.1 mg/dL | Standard Deviation 33.3 |
| Treatment | Mean Glucose | Night Time Phase 2 | 140.7 mg/dL | Standard Deviation 16.4 |
| Treatment | Mean Glucose | Night Time Phase 3 | 145.7 mg/dL | Standard Deviation 16.9 |
| Treatment | Mean Glucose | Overall ST | 171.1 mg/dL | Standard Deviation 30.5 |
| Treatment | Mean Glucose | Overall Phase 2 | 157.4 mg/dL | Standard Deviation 16.8 |
| Treatment | Mean Glucose | Overall Phase 3 | 159.1 mg/dL | Standard Deviation 17.9 |
Secondary
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage in Automated and Manual modes. Percentage of time in Automated and Manual mode do not add up to 100% due to missing data from participants not using the Omnipod 5 system (e.g., not wearing a Pod).
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (450 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 2 Automated Mode | 96.8 percent of time | Standard Deviation 2.6 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 2 Manual Mode | 2.8 percent of time | Standard Deviation 2.5 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 3 Automated Mode | 95.5 percent of time | Standard Deviation 3.8 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 3 Manual Mode | 3.2 percent of time | Standard Deviation 3.2 |
Secondary
Percent of Time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time > 180 mg/dL | Day Time ST | 39.7 percent of time | Standard Deviation 16.6 |
| Treatment | Percent of Time > 180 mg/dL | Day Time Phase 2 | 33.7 percent of time | Standard Deviation 10.7 |
| Treatment | Percent of Time > 180 mg/dL | Day Time Phase 3 | 33.7 percent of time | Standard Deviation 10.8 |
| Treatment | Percent of Time > 180 mg/dL | Night Time ST | 38.4 percent of time | Standard Deviation 20.1 |
| Treatment | Percent of Time > 180 mg/dL | Night Time Phase 2 | 16.9 percent of time | Standard Deviation 10.3 |
| Treatment | Percent of Time > 180 mg/dL | Night Time Phase 3 | 19.7 percent of time | Standard Deviation 10.6 |
| Treatment | Percent of Time > 180 mg/dL | Overall ST | 39.4 percent of time | Standard Deviation 16.7 |
| Treatment | Percent of Time > 180 mg/dL | Overall Phase 2 | 29.5 percent of time | Standard Deviation 9.8 |
| Treatment | Percent of Time > 180 mg/dL | Overall Phase 3 | 30.2 percent of time | Standard Deviation 10.1 |
Secondary
Percent of Time ≥ 250 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time ST | 15.4 percent of time | Standard Deviation 12.7 |
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time Phase 2 | 11.0 percent of time | Standard Deviation 6.6 |
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time Phase 3 | 11.5 percent of time | Standard Deviation 6.9 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time ST | 13.0 percent of time | Standard Deviation 13.2 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time Phase 2 | 3.9 percent of time | Standard Deviation 3.9 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time Phase 3 | 5.1 percent of time | Standard Deviation 4.6 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall ST | 14.8 percent of time | Standard Deviation 12.1 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall Phase 2 | 9.2 percent of time | Standard Deviation 5.6 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall Phase 3 | 9.9 percent of time | Standard Deviation 6 |
Secondary
Percent of Time ≥ 300 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time ST | 4.3 percent of time | Standard Deviation 6.7 |
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time Phase 2 | 1.2 percent of time | Standard Deviation 1.6 |
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time Phase 3 | 1.8 percent of time | Standard Deviation 2.1 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall ST | 6.0 percent of time | Standard Deviation 7.3 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall Phase 2 | 3.2 percent of time | Standard Deviation 2.8 |
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time ST | 6.5 percent of time | Standard Deviation 8 |
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time Phase 2 | 3.9 percent of time | Standard Deviation 3.4 |
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time Phase 3 | 4.4 percent of time | Standard Deviation 3.8 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall Phase 3 | 3.7 percent of time | Standard Deviation 3.2 |
Secondary
Percent of Time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 54 mg/dL | Night Time ST | 0.85 percent of time | Standard Deviation 1.94 |
| Treatment | Percent of Time < 54 mg/dL | Night Time Phase 2 | 0.39 percent of time | Standard Deviation 0.53 |
| Treatment | Percent of Time < 54 mg/dL | Night Time Phase 3 | 0.49 percent of time | Standard Deviation 0.63 |
| Treatment | Percent of Time < 54 mg/dL | Overall ST | 0.81 percent of time | Standard Deviation 1.68 |
| Treatment | Percent of Time < 54 mg/dL | Overall Phase 2 | 0.47 percent of time | Standard Deviation 0.54 |
| Treatment | Percent of Time < 54 mg/dL | Overall Phase 3 | 0.57 percent of time | Standard Deviation 0.6 |
| Treatment | Percent of Time < 54 mg/dL | Day Time ST | 0.80 percent of time | Standard Deviation 1.67 |
| Treatment | Percent of Time < 54 mg/dL | Day Time Phase 2 | 0.50 percent of time | Standard Deviation 0.61 |
| Treatment | Percent of Time < 54 mg/dL | Day Time Phase 3 | 0.59 percent of time | Standard Deviation 0.63 |
Secondary
Percent of Time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 70 mg/dL | Day Time ST | 3.44 percent of time | Standard Deviation 3.85 |
| Treatment | Percent of Time < 70 mg/dL | Day Time Phase 2 | 2.57 percent of time | Standard Deviation 1.99 |
| Treatment | Percent of Time < 70 mg/dL | Day Time Phase 3 | 2.79 percent of time | Standard Deviation 1.98 |
| Treatment | Percent of Time < 70 mg/dL | Night Time ST | 3.41 percent of time | Standard Deviation 4.79 |
| Treatment | Percent of Time < 70 mg/dL | Night Time Phase 2 | 2.13 percent of time | Standard Deviation 1.94 |
| Treatment | Percent of Time < 70 mg/dL | Night Time Phase 3 | 2.06 percent of time | Standard Deviation 1.7 |
| Treatment | Percent of Time < 70 mg/dL | Overall ST | 3.43 percent of time | Standard Deviation 3.87 |
| Treatment | Percent of Time < 70 mg/dL | Overall Phase 2 | 2.46 percent of time | Standard Deviation 1.83 |
| Treatment | Percent of Time < 70 mg/dL | Overall Phase 3 | 2.61 percent of time | Standard Deviation 1.82 |
Secondary
Percent of Time in Range 70-140 mg/dL
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time ST | 36.2 percent time in range | Standard Deviation 13.2 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time Phase 2 | 41.3 percent time in range | Standard Deviation 9.4 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time Phase 3 | 41.2 percent time in range | Standard Deviation 9.8 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time ST | 36.7 percent time in range | Standard Deviation 16.9 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time Phase 2 | 57.7 percent time in range | Standard Deviation 13.7 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time Phase 3 | 53.9 percent time in range | Standard Deviation 13.1 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall ST | 36.3 percent time in range | Standard Deviation 13.4 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall Phase 2 | 45.4 percent time in range | Standard Deviation 9.7 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall Phase 3 | 44.4 percent time in range | Standard Deviation 10 |
Secondary
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Standard Deviation | Day Time Phase 2 | 62.2 mg/dL | Standard Deviation 10.5 |
| Treatment | Standard Deviation | Day Time Phase 3 | 63.4 mg/dL | Standard Deviation 11.3 |
| Treatment | Standard Deviation | Night Time ST | 58.0 mg/dL | Standard Deviation 14 |
| Treatment | Standard Deviation | Night Time Phase 2 | 45.5 mg/dL | Standard Deviation 10.8 |
| Treatment | Standard Deviation | Day Time ST | 66.1 mg/dL | Standard Deviation 13.7 |
| Treatment | Standard Deviation | Night Time Phase 3 | 48.8 mg/dL | Standard Deviation 11.7 |
| Treatment | Standard Deviation | Overall ST | 64.9 mg/dL | Standard Deviation 13.4 |
| Treatment | Standard Deviation | Overall Phase 2 | 59.6 mg/dL | Standard Deviation 10.3 |
| Treatment | Standard Deviation | Overall Phase 3 | 60.9 mg/dL | Standard Deviation 11.1 |
Secondary
Total Daily Basal Insulin (Units)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Basal Insulin (Units) | ST | 5.6 units | Standard Deviation 2.5 |
| Treatment | Total Daily Basal Insulin (Units) | Phase 2 | 6.4 units | Standard Deviation 2.4 |
| Treatment | Total Daily Basal Insulin (Units) | Phase 3 | 7.7 units | Standard Deviation 2.8 |
Secondary
Total Daily Basal Insulin (Units/kg)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Basal Insulin (Units/kg) | Phase 3 | 0.38 units/kg | Standard Deviation 0.11 |
| Treatment | Total Daily Basal Insulin (Units/kg) | ST | 0.28 units/kg | Standard Deviation 0.12 |
| Treatment | Total Daily Basal Insulin (Units/kg) | Phase 2 | 0.32 units/kg | Standard Deviation 0.1 |
Secondary
Total Daily Bolus Insulin (Units)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Bolus Insulin (Units) | ST | 8.1 units | Standard Deviation 3.3 |
| Treatment | Total Daily Bolus Insulin (Units) | Phase 2 | 7.7 units | Standard Deviation 2.3 |
| Treatment | Total Daily Bolus Insulin (Units) | Phase 3 | 8.7 units | Standard Deviation 2.5 |
Secondary
Total Daily Bolus Insulin (Units/kg)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Bolus Insulin (Units/kg) | ST | 0.41 units/kg | Standard Deviation 0.15 |
| Treatment | Total Daily Bolus Insulin (Units/kg) | Phase 2 | 0.39 units/kg | Standard Deviation 0.1 |
| Treatment | Total Daily Bolus Insulin (Units/kg) | Phase 3 | 0.42 units/kg | Standard Deviation 0.11 |
Secondary
Total Daily Insulin (TDI) (Units)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Insulin (TDI) (Units) | ST | 13.7 units | Standard Deviation 4.4 |
| Treatment | Total Daily Insulin (TDI) (Units) | Phase 2 | 14.1 units | Standard Deviation 4 |
| Treatment | Total Daily Insulin (TDI) (Units) | Phase 3 | 16.4 units | Standard Deviation 4.5 |
Secondary
Total Daily Insulin (TDI) (Units/kg)
Measure of insulin requirements
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to the Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Insulin (TDI) (Units/kg) | ST | 0.69 units/kg | Standard Deviation 0.18 |
| Treatment | Total Daily Insulin (TDI) (Units/kg) | Phase 2 | 0.71 units/kg | Standard Deviation 0.15 |
| Treatment | Total Daily Insulin (TDI) (Units/kg) | Phase 3 | 0.80 units/kg | Standard Deviation 0.17 |