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 (Phase 1 or ST) 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 (Phase 2), 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 (Phase 3). During the hybrid closed-loop phase, there will be supervised exercise challenges. A subset of subjects will participate in 5-days of supervised Meal and Exercise challenges. A subset of subjects will participate in 3-days of supervised HypoProtect Exercise challenges where comparisons were made between exercising in Automated Mode vs initiating HypoProtect 60 minutes prior to exercise vs initiating HypoProtect 30 minutes prior to exercise. 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
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 travel to and participate in meal and exercise challenges during 5-days of the hybrid closed-loop phase 8. Willing to wear the system continuously throughout the study 9. A1C \<10% at screening visit 10. Must be willing to use the Dexcom App on the Omnipod Horizon™ Personal Diabetes Manager (PDM) as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase 11. 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 12. Able to read and speak English fluently 13. 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 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. 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 other than the Omnipod Horizon™ Automated Glucose Control System 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 |
|---|---|---|
| Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | Phase 2 hybrid closed-loop (94 days) | Measure of serious device-related adverse events |
| Time in Range 70-180 mg/dL | Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days) | Measures device effectiveness |
| Glycated Hemoglobin (A1C) | 6 weeks continuous Phase 2 participation compared to baseline | Measures device effectiveness |
| Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | Phase 2 hybrid closed-loop (94 days) | Measure of serious device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Daily Bolus Insulin (Units/kg) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) | Measure of insulin requirements |
| Percent of Time in Range 70-180 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 in Range 70-140 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 ≥ 300 mg/dL | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 (270 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 (of Glucose) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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) |
| Percent Coefficient of Variation (of Glucose) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period. |
| Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days) | Measure of system usage |
| Percent Glucose Management Indicator (% GMI) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of \<7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more). |
| Total Daily Insulin (TDI) (Units) | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 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 (270 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 (270 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 (270 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 (270 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 (270 days) compared to baseline | Measure of change in weight |
| Percent of Time >180 mg/dL | Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days) | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time <70 mg/dL | Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days) | Glucose metric from study continuous glucose monitoring system (CGM) |
| Glycated Hemoglobin (A1C) | at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days) | Measures device effectiveness |
| Mean Glucose | Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall | Glucose metric from study continuous glucose monitoring system (CGM) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Minimum Continuous Glucose Monitor Value (Nadir Glucose) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Measure of device effectiveness |
| Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Measure of device effectiveness |
| Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Measure of device effectiveness |
| Carbohydrates Consumed During Exercise (Grams) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Measure of device effectiveness |
| Mean Glucose | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Glucose metric from study continuous glucose monitoring system (CGM) |
| Percent of Time in Range 70-180 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
| Percent of Time ≥ 300 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
| Percent of Time < 70 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
| Percent of Time < 54 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
| Standard Deviation (of Glucose) | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) |
| Coefficient of Variation (of Glucose) | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period. |
| Percent of Time > 180 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
| Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Measure of device effectiveness |
| Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) | HypoProtect compared to Automated Mode (3-day exercise challenge) | Number of hypoglycemic events less than 70mg/dL which was confirmed with a blood glucose reading. |
| Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) | HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge) | Measure of device safety |
| Percent of Time ≥ 250 mg/dL | Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise | Measure of device effectiveness |
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 | 240 |
| Total | 240 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 24.5 years STANDARD_DEVIATION 16.8 |
| BMI | 22.8 kg/m^2 STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 4 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 228 Participants |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 1 / 224 |
| other Total, other adverse events | 36 / 240 | 107 / 224 |
| serious Total, serious adverse events | 6 / 240 | 19 / 224 |
Outcome results
Primary
Glycated Hemoglobin (A1C)
Measures device effectiveness
Time frame: 6 weeks continuous Phase 2 participation compared to baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glycated Hemoglobin (A1C) | Baseline | 7.4 percentage of HbA1C | Standard Deviation 0.9 |
| Treatment | Glycated Hemoglobin (A1C) | Phase 2 | 6.9 percentage of HbA1C | Standard Deviation 0.7 |
Primary
Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months)
Measure of serious device-related adverse events
Time frame: Phase 2 hybrid closed-loop (94 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) | .001 events per person month |
Primary
Incidence Rate of Severe Hypoglycemia (Events Per Person Months)
Measure of serious device-related adverse events
Time frame: Phase 2 hybrid closed-loop (94 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Incidence Rate of Severe Hypoglycemia (Events Per Person Months) | .004 events per person month |
Primary
Time in Range 70-180 mg/dL
Measures device effectiveness
Time frame: Phase 2 hybrid closed-loop (94 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 | 58.6 % Time in Range | Standard Deviation 17.5 |
| Treatment | Time in Range 70-180 mg/dL | Day Time Phase 2 | 68.8 % Time in Range | Standard Deviation 10.7 |
| Treatment | Time in Range 70-180 mg/dL | Night Time ST | 60.1 % Time in Range | Standard Deviation 19.8 |
| Treatment | Time in Range 70-180 mg/dL | Night Time Phase 2 | 78.1 % Time in Range | Standard Deviation 12.6 |
| Treatment | Time in Range 70-180 mg/dL | Overall ST | 59.0 % Time in Range | Standard Deviation 17.2 |
| Treatment | Time in Range 70-180 mg/dL | Overall Phase 2 | 71.2 % Time in Range | Standard Deviation 10.2 |
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 (270 days) compared to baseline
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Body Mass Index (BMI) (kg/m^2) | Phase 3 | 23.8 kg/m^2 | Standard Deviation 5.6 |
| Treatment | Body Mass Index (BMI) (kg/m^2) | Baseline | 22.8 kg/m^2 | Standard Deviation 5.7 |
| Treatment | Body Mass Index (BMI) (kg/m^2) | Phase 2 | 23.0 kg/m^2 | Standard Deviation 5.5 |
Secondary
Glycated Hemoglobin (A1C)
Measures device effectiveness
Time frame: at least 6 weeks and at least 8 weeks of continuous Phase 2 participation, end of Phase 2 (94 days), 6 months (180 days) and end of Phase 3 (270 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Glycated Hemoglobin (A1C) | 12 months | 7.1 % A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | 6 Weeks Baseline | 7.4 % A1C | Standard Deviation 0.9 |
| Treatment | Glycated Hemoglobin (A1C) | 6 Weeks Phase 2 | 6.7 % A1C | Standard Deviation 0.6 |
| Treatment | Glycated Hemoglobin (A1C) | 8 Weeks Baseline | 7.4 % A1C | Standard Deviation 0.9 |
| Treatment | Glycated Hemoglobin (A1C) | 8 Weeks Phase 2 | 6.9 % A1C | Standard Deviation 0.7 |
| Treatment | Glycated Hemoglobin (A1C) | 6 months | 6.8 % A1C | Standard Deviation 0.6 |
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 (270 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 | 172.7 mg/dL | Standard Deviation 32.2 |
| Treatment | Mean Glucose | Day Time Phase 2 | 159.4 mg/dL | Standard Deviation 17.1 |
| Treatment | Mean Glucose | Day Time Phase 3 | 162.2 mg/dL | Standard Deviation 19.7 |
| Treatment | Mean Glucose | Night Time ST | 167.8 mg/dL | Standard Deviation 35.4 |
| Treatment | Mean Glucose | Night Time Phase 2 | 148.9 mg/dL | Standard Deviation 19.2 |
| Treatment | Mean Glucose | Night Time Phase 3 | 150.8 mg/dL | Standard Deviation 19.3 |
| Treatment | Mean Glucose | Overall ST | 171.5 mg/dL | Standard Deviation 31.7 |
| Treatment | Mean Glucose | Overall Phase 2 | 156.7 mg/dL | Standard Deviation 16.3 |
| Treatment | Mean Glucose | Overall Phase 3 | 159.3 mg/dL | Standard Deviation 18.4 |
Secondary
Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time
Measure of system usage
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| 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 | 95 Percent time spent | Standard Deviation 5.2 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 2 Manual Mode | 4.2 Percent time spent | Standard Deviation 4.7 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 3 Automated Mode | 93.6 Percent time spent | Standard Deviation 7.7 |
| Treatment | Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time | Phase 3 Manual Mode | 4.9 Percent time spent | Standard Deviation 6.9 |
Secondary
Percent Coefficient of Variation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)- measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent Coefficient of Variation (of Glucose) | Day Time ST | 36.1 Percent coefficient of variation | Standard Deviation 5.7 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Day Time Phase 2 | 34.6 Percent coefficient of variation | Standard Deviation 5.2 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Day Time Phase 3 | 35.4 Percent coefficient of variation | Standard Deviation 5.2 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Night Time ST | 34.9 Percent coefficient of variation | Standard Deviation 7.5 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Night Time Phase 2 | 30.3 Percent coefficient of variation | Standard Deviation 5.9 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Night Time Phase 3 | 32.1 Percent coefficient of variation | Standard Deviation 6.2 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Overall ST | 36.3 Percent coefficient of variation | Standard Deviation 5.6 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Overall Phase 2 | 34.2 Percent coefficient of variation | Standard Deviation 5.1 |
| Treatment | Percent Coefficient of Variation (of Glucose) | Overall Phase 3 | 35.2 Percent coefficient of variation | Standard Deviation 5.2 |
Secondary
Percent 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. Percent GMI provides information to a person with diabetes with how well their glucose is controlled over an extended period of time. A low value is more desirable than a high value, with a value of \<7% being ideal for most people with diabetes. The calculation for GMI is as follows: GMI (%) = 3.31 + 0.02392 x (mean glucose reading in mg/dL from the last 14 days or more).
Time frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent Glucose Management Indicator (% GMI) | Overall ST | 7.41 Percent GMI | Standard Deviation 0.76 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Day Time ST | 7.44 Percent GMI | Standard Deviation 0.77 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Day Time Phase 2 | 7.12 Percent GMI | Standard Deviation 0.41 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Day Time Phase 3 | 7.19 Percent GMI | Standard Deviation 0.47 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Night Time ST | 7.32 Percent GMI | Standard Deviation 0.85 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Night Time Phase 2 | 6.87 Percent GMI | Standard Deviation 0.46 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Night Time Phase 3 | 6.92 Percent GMI | Standard Deviation 0.46 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Overall Phase 2 | 7.06 Percent GMI | Standard Deviation 0.39 |
| Treatment | Percent Glucose Management Indicator (% GMI) | Overall Phase 3 | 7.12 Percent GMI | Standard Deviation 0.44 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time >180 mg/dL | Day Time ST | 39.0 Percent Time in Range | Standard Deviation 18.4 |
| Treatment | Percent of Time >180 mg/dL | Day Time Phase 2 | 29.5 Percent Time in Range | Standard Deviation 11 |
| Treatment | Percent of Time >180 mg/dL | Day Time Phase 3 | 31.3 Percent Time in Range | Standard Deviation 11.9 |
| Treatment | Percent of Time >180 mg/dL | Night Time ST | 36.8 Percent Time in Range | Standard Deviation 20.7 |
| Treatment | Percent of Time >180 mg/dL | Night Time Phase 2 | 20.7 Percent Time in Range | Standard Deviation 12.6 |
| Treatment | Percent of Time >180 mg/dL | Night Time Phase 3 | 22.0 Percent Time in Range | Standard Deviation 12.6 |
| Treatment | Percent of Time >180 mg/dL | Overall ST | 38.5 Percent Time in Range | Standard Deviation 18.1 |
| Treatment | Percent of Time >180 mg/dL | Overall Phase 2 | 27.3 Percent Time in Range | Standard Deviation 10.5 |
| Treatment | Percent of Time >180 mg/dL | Overall Phase 3 | 28.9 Percent Time in Range | Standard Deviation 11.2 |
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) compared to Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time >180 mg/dL | Day Time ST | 39 % Time in Range | Standard Deviation 18.4 |
| Treatment | Percent of Time >180 mg/dL | Day Time HCL | 29.5 % Time in Range | Standard Deviation 11 |
| Treatment | Percent of Time >180 mg/dL | Night Time ST | 36.8 % Time in Range | Standard Deviation 20.7 |
| Treatment | Percent of Time >180 mg/dL | Night Time HCL | 20.7 % Time in Range | Standard Deviation 12.6 |
| Treatment | Percent of Time >180 mg/dL | Overall ST | 38.5 % Time in Range | Standard Deviation 18.1 |
| Treatment | Percent of Time >180 mg/dL | Overall HCL | 27.3 % Time in Range | Standard Deviation 10.5 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time ST | 14.7 Percent Time in Range | Standard Deviation 12.9 |
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time Phase 2 | 8.4 Percent Time in Range | Standard Deviation 6.3 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time ST | 13.2 Percent Time in Range | Standard Deviation 14 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time Phase 2 | 5.1 Percent Time in Range | Standard Deviation 6.2 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall ST | 14.3 Percent Time in Range | Standard Deviation 12.5 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall Phase 2 | 7.6 Percent Time in Range | Standard Deviation 5.8 |
| Treatment | Percent of Time ≥ 250 mg/dL | Day Time Phase 3 | 9.8 Percent Time in Range | Standard Deviation 7.4 |
| Treatment | Percent of Time ≥ 250 mg/dL | Night Time Phase 3 | 6.1 Percent Time in Range | Standard Deviation 6.1 |
| Treatment | Percent of Time ≥ 250 mg/dL | Overall Phase 3 | 8.9 Percent Time in Range | Standard Deviation 6.7 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time ST | 6.2 Percent Time in Range | Standard Deviation 7.9 |
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time Phase 2 | 2.8 Percent Time in Range | Standard Deviation 3.1 |
| Treatment | Percent of Time ≥ 300 mg/dL | Day Time Phase 3 | 3.7 Percent Time in Range | Standard Deviation 4.2 |
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time ST | 5.4 Percent Time in Range | Standard Deviation 8.6 |
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time Phase 2 | 1.7 Percent Time in Range | Standard Deviation 2.8 |
| Treatment | Percent of Time ≥ 300 mg/dL | Night Time Phase 3 | 2.2 Percent Time in Range | Standard Deviation 3.4 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall ST | 6.0 Percent Time in Range | Standard Deviation 7.7 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall Phase 2 | 2.5 Percent Time in Range | Standard Deviation 2.8 |
| Treatment | Percent of Time ≥ 300 mg/dL | Overall Phase 3 | 3.3 Percent Time in Range | Standard Deviation 3.9 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 54 mg/dL | Day Time ST | 0.44 Percent Time in Range | Standard Deviation 0.99 |
| Treatment | Percent of Time < 54 mg/dL | Day Time Phase 2 | 0.29 Percent Time in Range | Standard Deviation 0.32 |
| Treatment | Percent of Time < 54 mg/dL | Day Time Phase 3 | 0.33 Percent Time in Range | Standard Deviation 0.38 |
| Treatment | Percent of Time < 54 mg/dL | Night Time ST | 0.77 Percent Time in Range | Standard Deviation 1.77 |
| Treatment | Percent of Time < 54 mg/dL | Night Time Phase 2 | 0.23 Percent Time in Range | Standard Deviation 0.35 |
| Treatment | Percent of Time < 54 mg/dL | Night Time Phase 3 | 0.34 Percent Time in Range | Standard Deviation 0.51 |
| Treatment | Percent of Time < 54 mg/dL | Overall ST | 0.52 Percent Time in Range | Standard Deviation 1.07 |
| Treatment | Percent of Time < 54 mg/dL | Overall Phase 2 | 0.27 Percent Time in Range | Standard Deviation 0.3 |
| Treatment | Percent of Time < 54 mg/dL | Overall Phase 3 | 0.33 Percent Time in Range | Standard Deviation 0.37 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 70 mg/dL | Day Time ST | 2.40 Percent Time in Range | Standard Deviation 2.78 |
| Treatment | Percent of Time < 70 mg/dL | Day Time Phase 2 | 1.66 Percent Time in Range | Standard Deviation 1.38 |
| Treatment | Percent of Time < 70 mg/dL | Day Time Phase 3 | 1.75 Percent Time in Range | Standard Deviation 1.5 |
| Treatment | Percent of Time < 70 mg/dL | Night Time ST | 3.11 Percent Time in Range | Standard Deviation 4.39 |
| Treatment | Percent of Time < 70 mg/dL | Night Time Phase 2 | 1.17 Percent Time in Range | Standard Deviation 1.23 |
| Treatment | Percent of Time < 70 mg/dL | Night Time Phase 3 | 1.38 Percent Time in Range | Standard Deviation 1.46 |
| Treatment | Percent of Time < 70 mg/dL | Overall ST | 2.57 Percent Time in Range | Standard Deviation 2.9 |
| Treatment | Percent of Time < 70 mg/dL | Overall Phase 2 | 1.53 Percent Time in Range | Standard Deviation 1.25 |
| Treatment | Percent of Time < 70 mg/dL | Overall Phase 3 | 1.66 Percent Time in Range | Standard Deviation 1.38 |
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) compared to Phase 1 standard therapy (14 days)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time <70 mg/dL | Day Time ST | 2.4 % Time in Range | Standard Deviation 2.78 |
| Treatment | Percent of Time <70 mg/dL | Day Time HCL | 1.66 % Time in Range | Standard Deviation 1.38 |
| Treatment | Percent of Time <70 mg/dL | Night Time ST | 3.11 % Time in Range | Standard Deviation 4.39 |
| Treatment | Percent of Time <70 mg/dL | Night Time HCL | 1.17 % Time in Range | Standard Deviation 1.23 |
| Treatment | Percent of Time <70 mg/dL | Overall ST | 2.57 % Time in Range | Standard Deviation 2.9 |
| Treatment | Percent of Time <70 mg/dL | Overall HCL | 1.53 % Time in Range | Standard Deviation 1.25 |
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time ST | 36.0 Percent Time in Range | Standard Deviation 15.3 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time Phase 2 | 43.7 Percent Time in Range | Standard Deviation 10.6 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Day Time Phase 3 | 42.6 Percent Time in Range | Standard Deviation 11.1 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time ST | 38.2 Percent Time in Range | Standard Deviation 19 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time Phase 2 | 52.8 Percent Time in Range | Standard Deviation 15.5 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Night Time Phase 3 | 51.9 Percent Time in Range | Standard Deviation 14.4 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall ST | 36.6 Percent Time in Range | Standard Deviation 15.4 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall Phase 2 | 46.0 Percent Time in Range | Standard Deviation 10.7 |
| Treatment | Percent of Time in Range 70-140 mg/dL | Overall Phase 3 | 45.0 Percent Time in Range | Standard Deviation 10.8 |
Secondary
Percent of Time in Range 70-180 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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time in Range 70-180 mg/dL | Day Time Phase 3 | 67.0 Percent Time in Range | Standard Deviation 11.5 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Day Time ST | 58.6 Percent Time in Range | Standard Deviation 17.5 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Day Time Phase 2 | 68.8 Percent Time in Range | Standard Deviation 10.7 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Night Time ST | 60.1 Percent Time in Range | Standard Deviation 19.8 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Night Time Phase 2 | 78.1 Percent Time in Range | Standard Deviation 12.6 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Night Time Phase 3 | 76.6 Percent Time in Range | Standard Deviation 12.5 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Overall ST | 59.0 Percent Time in Range | Standard Deviation 17.2 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Overtime Phase 2 | 71.2 Percent Time in Range | Standard Deviation 10.2 |
| Treatment | Percent of Time in Range 70-180 mg/dL | Overtime Phase 3 | 69.4 Percent Time in Range | Standard Deviation 10.8 |
Secondary
Standard Deviation (of Glucose)
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 (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Standard Deviation (of Glucose) | Day Time ST | 62.4 mg/dL | Standard Deviation 15.2 |
| Treatment | Standard Deviation (of Glucose) | Day Time Phase 2 | 55.5 mg/dL | Standard Deviation 11.9 |
| Treatment | Standard Deviation (of Glucose) | Day Time Phase 3 | 57.9 mg/dL | Standard Deviation 13.3 |
| Treatment | Standard Deviation (of Glucose) | Night Time ST | 58.3 mg/dL | Standard Deviation 16.3 |
| Treatment | Standard Deviation (of Glucose) | Night Time Phase 2 | 45.6 mg/dL | Standard Deviation 12.8 |
| Treatment | Standard Deviation (of Glucose) | Night Time Phase 3 | 49.0 mg/dL | Standard Deviation 13.9 |
| Treatment | Standard Deviation (of Glucose) | Overall ST | 62.3 mg/dL | Standard Deviation 14.9 |
| Treatment | Standard Deviation (of Glucose) | Overall Phase 2 | 53.9 mg/dL | Standard Deviation 11.6 |
| Treatment | Standard Deviation (of Glucose) | Overall Phase 3 | 56.5 mg/dL | Standard Deviation 13 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Basal Insulin (Units) | ST | 19.7 units of insulin | Standard Deviation 10.7 |
| Treatment | Total Daily Basal Insulin (Units) | Phase 2 | 21.4 units of insulin | Standard Deviation 10.5 |
| Treatment | Total Daily Basal Insulin (Units) | Phase 3 | 24.3 units of insulin | Standard Deviation 10.8 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Basal Insulin (Units/kg) | Phase 3 | 0.43 units of insulin/kg | Standard Deviation 0.18 |
| Treatment | Total Daily Basal Insulin (Units/kg) | ST | 0.33 units of insulin/kg | Standard Deviation 0.12 |
| Treatment | Total Daily Basal Insulin (Units/kg) | Phase 2 | 0.38 units of insulin/kg | Standard Deviation 0.15 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed in Phase 2. 224 subjects were analyzed in Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Bolus Insulin (Units) | ST | 21.8 units of insulin | Standard Deviation 12.7 |
| Treatment | Total Daily Bolus Insulin (Units) | Phase 2 | 20.7 units of insulin | Standard Deviation 10.1 |
| Treatment | Total Daily Bolus Insulin (Units) | Phase 3 | 22.0 units of insulin | Standard Deviation 10.9 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Bolus Insulin (Units/kg) | ST | 0.39 units of insulin/kg | Standard Deviation 0.19 |
| Treatment | Total Daily Bolus Insulin (Units/kg) | Phase 2 | 0.37 units of insulin/kg | Standard Deviation 0.15 |
| Treatment | Total Daily Bolus Insulin (Units/kg) | Phase 3 | 0.38 units of insulin/kg | Standard Deviation 0.17 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Insulin (TDI) (Units) | ST | 41.7 units of insulin | Standard Deviation 20.6 |
| Treatment | Total Daily Insulin (TDI) (Units) | Phase 2 | 42.1 units of insulin | Standard Deviation 19.3 |
| Treatment | Total Daily Insulin (TDI) (Units) | Phase 3 | 46.3 units of insulin | Standard Deviation 20.1 |
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 (270 days) compared to the Phase 1 standard therapy (14 days)
Population: 240 subjects were analyzed for Phase 2. 224 subjects were analyzed for Phase 3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Total Daily Insulin (TDI) (Units/kg) | ST | 0.72 units of insulin/kg | Standard Deviation 0.26 |
| Treatment | Total Daily Insulin (TDI) (Units/kg) | Phase 2 | 0.75 units of insulin/kg | Standard Deviation 0.28 |
| Treatment | Total Daily Insulin (TDI) (Units/kg) | Phase 3 | 0.81 units of insulin/kg | Standard Deviation 0.32 |
Other Pre-specified
Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value)
Measure of device effectiveness
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) | Automated Mode | 66.7 hours x mg/dL | Standard Deviation 243.4 |
| Treatment | Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) | HPt-60 | 30.0 hours x mg/dL | Standard Deviation 113 |
| Treatment | Area Under the Curve (AUC) Greater Than 180 mg/dL (Based on CGM Value) | HPt-30 | 82.8 hours x mg/dL | Standard Deviation 400.7 |
Other Pre-specified
Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value)
Measure of device effectiveness
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) | Automated Mode | 58.3 hours x mg/dL | Standard Deviation 144.7 |
| Treatment | Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) | HPt-60 | 34.0 hours x mg/dL | Standard Deviation 83.9 |
| Treatment | Area Under the Curve (AUC) Less Than 70 mg/dL (Based on CGM Value) | HPt-30 | 34.3 hours x mg/dL | Standard Deviation 77.6 |
Other Pre-specified
Carbohydrates Consumed During Exercise (Grams)
Measure of device effectiveness
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Carbohydrates Consumed During Exercise (Grams) | Automated Mode | 12.0 grams | Standard Deviation 15.5 |
| Treatment | Carbohydrates Consumed During Exercise (Grams) | HPt-60 | 10.1 grams | Standard Deviation 14.2 |
| Treatment | Carbohydrates Consumed During Exercise (Grams) | HPt-30 | 8.8 grams | Standard Deviation 12.3 |
Other Pre-specified
Coefficient of Variation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV). Calculated by dividing the standard deviation of CGM values by the mean CGM values in the observation period.
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Coefficient of Variation (of Glucose) | During Exercise Automated Mode | 21.6 Percent coefficient of variation | Standard Deviation 11.7 |
| Treatment | Coefficient of Variation (of Glucose) | During Exercise HPT-60 | 17.1 Percent coefficient of variation | Standard Deviation 10.4 |
| Treatment | Coefficient of Variation (of Glucose) | During Exercise HPT-30 | 17.2 Percent coefficient of variation | Standard Deviation 11.2 |
| Treatment | Coefficient of Variation (of Glucose) | 4 Hours Post Exercise Automated Mode | 25.9 Percent coefficient of variation | Standard Deviation 8.5 |
| Treatment | Coefficient of Variation (of Glucose) | 4 Hours Post Exercise HPt-60 | 23.6 Percent coefficient of variation | Standard Deviation 8.4 |
| Treatment | Coefficient of Variation (of Glucose) | 4 Hours Post Exercise HPt-30 | 24.5 Percent coefficient of variation | Standard Deviation 10.7 |
| Treatment | Coefficient of Variation (of Glucose) | 12 Hours Post Exercise Automated Mode | 28.5 Percent coefficient of variation | Standard Deviation 8.1 |
| Treatment | Coefficient of Variation (of Glucose) | 12 Hours Post Exercise HPt-60 | 30.0 Percent coefficient of variation | Standard Deviation 9.8 |
| Treatment | Coefficient of Variation (of Glucose) | 12 Hours Post Exercise HPt-30 | 29.3 Percent coefficient of variation | Standard Deviation 8.6 |
| Treatment | Coefficient of Variation (of Glucose) | 24 Hours Post Exercise Automated Mode | 28.8 Percent coefficient of variation | Standard Deviation 6.3 |
| Treatment | Coefficient of Variation (of Glucose) | 24 Hours Post Exercise HPt-60 | 29.5 Percent coefficient of variation | Standard Deviation 8.6 |
| Treatment | Coefficient of Variation (of Glucose) | 24 Hours Post Exercise HPt-30 | 30.4 Percent coefficient of variation | Standard Deviation 7.5 |
Other Pre-specified
Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG)
Measure of device safety
Time frame: HypoProtect compared to standard Omnipod 5 system use (3-day exercise challenge)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) | Exercise in Automated Mode without use of HypoProtect. | 40.8 Percentage with hypoglycemia events |
| Treatment | Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) | Hpt-60 (HypoProtect started 60 min before exercise.) | 34.7 Percentage with hypoglycemia events |
| Treatment | Incidence Rate of Hypoglycemia (<70 mg/dL Confirmed by BG) | HPt-30 (HypoProtect started 30 min before exercise.) | 36.0 Percentage with hypoglycemia events |
Other Pre-specified
Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose)
Measure of device effectiveness
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) | Automated Mode | 58.1 mg/dL | Standard Deviation 35 |
| Treatment | Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) | HPt-60 | 47.8 mg/dL | Standard Deviation 35.6 |
| Treatment | Mean Absolute Decrease in Glucose (Based on CGM Value, From Start of Exercise to Nadir Glucose) | HPt-30 | 42.0 mg/dL | Standard Deviation 37.2 |
Other Pre-specified
Mean Glucose
Glucose metric from study continuous glucose monitoring system (CGM)
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Mean Glucose | During Exercise Automated Mode | 117.6 mg/dL | Standard Deviation 20.7 |
| Treatment | Mean Glucose | During Exercise HPt-60 | 123.2 mg/dL | Standard Deviation 26.9 |
| Treatment | Mean Glucose | During Exercise HPt-30 | 119.7 mg/dL | Standard Deviation 28.9 |
| Treatment | Mean Glucose | End of exercise through 4 hours post exercise Automated Mode | 150.6 mg/dL | Standard Deviation 39.7 |
| Treatment | Mean Glucose | End of exercise through 4 hours post exercise HPt-60 | 156.9 mg/dL | Standard Deviation 34.5 |
| Treatment | Mean Glucose | End of exercise through 4 hours post exercise HPt-30 | 167.2 mg/dL | Standard Deviation 45.8 |
| Treatment | Mean Glucose | End of exercise through 12 hours post exercise Automated Mode | 156.7 mg/dL | Standard Deviation 34.5 |
| Treatment | Mean Glucose | End of exercise through 12 hours post exercise HPt-60 | 153.6 mg/dL | Standard Deviation 28.4 |
| Treatment | Mean Glucose | End of exercise through 12 hours post exercise HPt-30 | 155.2 mg/dL | Standard Deviation 36.2 |
| Treatment | Mean Glucose | End of exercise through 24 hours post exercise Automated Mode | 150.8 mg/dL | Standard Deviation 25.7 |
| Treatment | Mean Glucose | End of exercise through 24 hours post exercise HPt-60 | 150.0 mg/dL | Standard Deviation 24.1 |
| Treatment | Mean Glucose | End of exercise through 24 hours post exercise HPt-30 | 151.4 mg/dL | Standard Deviation 26.3 |
Other Pre-specified
Minimum Continuous Glucose Monitor Value (Nadir Glucose)
Measure of device effectiveness
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Minimum Continuous Glucose Monitor Value (Nadir Glucose) | Automated Mode | 83.9 mg/dL | Standard Deviation 25 |
| Treatment | Minimum Continuous Glucose Monitor Value (Nadir Glucose) | HPt-60 | 94.9 mg/dL | Standard Deviation 33.1 |
| Treatment | Minimum Continuous Glucose Monitor Value (Nadir Glucose) | HPt-30 | 93.8 mg/dL | Standard Deviation 32.8 |
Other Pre-specified
Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG)
Number of hypoglycemic events less than 70mg/dL which was confirmed with a blood glucose reading.
Time frame: HypoProtect compared to Automated Mode (3-day exercise challenge)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) | Automated Mode | 23 Number of events |
| Treatment | Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) | HPt-60 | 19 Number of events |
| Treatment | Number of Hypoglycemic Events (<70 mg/dL Confirmed by BG) | HPt-30 | 19 Number of events |
Other Pre-specified
Percent of Time > 180 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time > 180 mg/dL | During Exercise Automated Mode | 4.5 Percent of time | Standard Deviation 11.4 |
| Treatment | Percent of Time > 180 mg/dL | During Exercise HPt-60 | 4.5 Percent of time | Standard Deviation 13 |
| Treatment | Percent of Time > 180 mg/dL | During Exercise HPt-30 | 4.6 Percent of time | Standard Deviation 18.6 |
| Treatment | Percent of Time > 180 mg/dL | 4 Hours Post Exercise Automated Mode | 27.9 Percent of time | Standard Deviation 28 |
| Treatment | Percent of Time > 180 mg/dL | 4 Hours Post Exercise HPt-60 | 30.9 Percent of time | Standard Deviation 25.9 |
| Treatment | Percent of Time > 180 mg/dL | 4 Hours Post Exercise HPt-30 | 31.7 Percent of time | Standard Deviation 28 |
| Treatment | Percent of Time > 180 mg/dL | 12 Hours Post Exercise Automated Mode | 30.5 Percent of time | Standard Deviation 24.1 |
| Treatment | Percent of Time > 180 mg/dL | 12 Hours Post Exercise HPt-60 | 27.3 Percent of time | Standard Deviation 19.9 |
| Treatment | Percent of Time > 180 mg/dL | 12 Hours Post Exercise HPt-30 | 26.4 Percent of time | Standard Deviation 22.9 |
| Treatment | Percent of Time > 180 mg/dL | 24 Hours Post Exercise Automated Mode | 24.1 Percent of time | Standard Deviation 17.5 |
| Treatment | Percent of Time > 180 mg/dL | 24 Hours Post Exercise HPt-60 | 23.3 Percent of time | Standard Deviation 16.9 |
| Treatment | Percent of Time > 180 mg/dL | 24 Hours Post Exercise HPt-30 | 23.1 Percent of time | Standard Deviation 16.9 |
Other Pre-specified
Percent of Time ≥ 250 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 250 mg/dL | During Exercise Automated Mode | 0.3 Percent of time | Standard Deviation 2.3 |
| Treatment | Percent of Time ≥ 250 mg/dL | During Exercise HPt-60 | 0.0 Percent of time | Standard Deviation 0 |
| Treatment | Percent of Time ≥ 250 mg/dL | During Exercise HPt-30 | 0.0 Percent of time | Standard Deviation 0 |
| Treatment | Percent of Time ≥ 250 mg/dL | 4 Hours Post Exercise Automated Mode | 6.3 Percent of time | Standard Deviation 14.7 |
| Treatment | Percent of Time ≥ 250 mg/dL | 4 Hours Post Exercise HPt-60 | 4.5 Percent of time | Standard Deviation 12.6 |
| Treatment | Percent of Time ≥ 250 mg/dL | 4 Hours Post Exercise HPt-30 | 12.0 Percent of time | Standard Deviation 21.2 |
| Treatment | Percent of Time ≥ 250 mg/dL | 12 Hours Post Exercise Automated Mode | 7.0 Percent of time | Standard Deviation 12.9 |
| Treatment | Percent of Time ≥ 250 mg/dL | 12 Hours Post Exercise HPt-60 | 7.1 Percent of time | Standard Deviation 11.2 |
| Treatment | Percent of Time ≥ 250 mg/dL | 12 Hours Post Exercise HPt-30 | 8.4 Percent of time | Standard Deviation 12.4 |
| Treatment | Percent of Time ≥ 250 mg/dL | 24 Hours Post Exercise Automated Mode | 5.3 Percent of time | Standard Deviation 8.5 |
| Treatment | Percent of Time ≥ 250 mg/dL | 24 Hours Post Exercise HPt-60 | 5.8 Percent of time | Standard Deviation 8.8 |
| Treatment | Percent of Time ≥ 250 mg/dL | 24 Hours Post Exercise HPt-30 | 7.0 Percent of time | Standard Deviation 9.5 |
Other Pre-specified
Percent of Time ≥ 300 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time ≥ 300 mg/dL | During Exercise Automated Mode | 0.0 percent of time | Standard Deviation 0 |
| Treatment | Percent of Time ≥ 300 mg/dL | During Exercise HPt-60 | 0.0 percent of time | Standard Deviation 0 |
| Treatment | Percent of Time ≥ 300 mg/dL | During Exercise HPt-30 | 0.0 percent of time | Standard Deviation 0 |
| Treatment | Percent of Time ≥ 300 mg/dL | 4 Hours Post Exercise Automated Mode | 1.4 percent of time | Standard Deviation 5.6 |
| Treatment | Percent of Time ≥ 300 mg/dL | 4 Hours Post Exercise HPt-60 | 1.8 percent of time | Standard Deviation 8.8 |
| Treatment | Percent of Time ≥ 300 mg/dL | 4 Hours Post Exercise HPt-30 | 5.3 percent of time | Standard Deviation 13.9 |
| Treatment | Percent of Time ≥ 300 mg/dL | 12 Hours Post Exercise Automated Mode | 2.4 percent of time | Standard Deviation 8.1 |
| Treatment | Percent of Time ≥ 300 mg/dL | 12 Hours Post Exercise HPt-60 | 2.5 percent of time | Standard Deviation 6 |
| Treatment | Percent of Time ≥ 300 mg/dL | 12 Hours Post Exercise HPt-30 | 3.3 percent of time | Standard Deviation 8 |
| Treatment | Percent of Time ≥ 300 mg/dL | 24 Hours Post Exercise Automated Mode | 1.6 percent of time | Standard Deviation 5.1 |
| Treatment | Percent of Time ≥ 300 mg/dL | 24 Hours Post Exercise HPt-60 | 1.7 percent of time | Standard Deviation 4.7 |
| Treatment | Percent of Time ≥ 300 mg/dL | 24 Hours Post Exercise HPt-30 | 2.2 percent of time | Standard Deviation 4.4 |
Other Pre-specified
Percent of Time < 54 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 54 mg/dL | During Exercise Automated Mode | 1.40 Percent of time | Standard Deviation 4.96 |
| Treatment | Percent of Time < 54 mg/dL | During Exercise HPT-60 | 0.52 Percent of time | Standard Deviation 2.12 |
| Treatment | Percent of Time < 54 mg/dL | During Exercise HPT-30 | 0.37 Percent of time | Standard Deviation 1.47 |
| Treatment | Percent of Time < 54 mg/dL | 4 Hours Post Exercise Automated Mode | 0.38 Percent of time | Standard Deviation 1.89 |
| Treatment | Percent of Time < 54 mg/dL | 4 Hours Post Exercise HPt-60 | 0.60 Percent of time | Standard Deviation 2.04 |
| Treatment | Percent of Time < 54 mg/dL | 4 Hours Post Exercise HPt-30 | 0.26 Percent of time | Standard Deviation 0.93 |
| Treatment | Percent of Time < 54 mg/dL | 12 Hours Post Exercise Automated Mode | 0.40 Percent of time | Standard Deviation 1.17 |
| Treatment | Percent of Time < 54 mg/dL | 12 Hours Post Exercise HPt-60 | 0.62 Percent of time | Standard Deviation 1.82 |
| Treatment | Percent of Time < 54 mg/dL | 12 Hours Post Exercise HPt-30 | 0.70 Percent of time | Standard Deviation 2.66 |
| Treatment | Percent of Time < 54 mg/dL | 24 Hours Post Exercise Automated Mode | 0.26 Percent of time | Standard Deviation 0.71 |
| Treatment | Percent of Time < 54 mg/dL | 24 Hours Post Exercise HPt-60 | 0.41 Percent of time | Standard Deviation 1.07 |
| Treatment | Percent of Time < 54 mg/dL | 24 Hours Post Exercise HPt-30 | 0.44 Percent of time | Standard Deviation 1.48 |
Other Pre-specified
Percent of Time < 70 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time < 70 mg/dL | During Exercise Automated Mode | 6.52 Percent of time | Standard Deviation 12.27 |
| Treatment | Percent of Time < 70 mg/dL | During Exercise HPt-60 | 5.12 Percent of time | Standard Deviation 9.06 |
| Treatment | Percent of Time < 70 mg/dL | During Exercise HPt-30 | 5.88 Percent of time | Standard Deviation 11.6 |
| Treatment | Percent of Time < 70 mg/dL | 4 Hours Post Exercise Automated Mode | 2.72 Percent of time | Standard Deviation 5.99 |
| Treatment | Percent of Time < 70 mg/dL | 4 Hours Post Exercise HPt-60 | 2.17 Percent of time | Standard Deviation 5.19 |
| Treatment | Percent of Time < 70 mg/dL | 4 Hours Post Exercise HPt-30 | 1.68 Percent of time | Standard Deviation 3.98 |
| Treatment | Percent of Time < 70 mg/dL | 12 Hours Post Exercise Automated Mode | 2.21 Percent of time | Standard Deviation 3.42 |
| Treatment | Percent of Time < 70 mg/dL | 12 Hours Post Exercise HPt-60 | 2.65 Percent of time | Standard Deviation 4.33 |
| Treatment | Percent of Time < 70 mg/dL | 12 Hours Post Exercise HPt-30 | 2.33 Percent of time | Standard Deviation 4.81 |
| Treatment | Percent of Time < 70 mg/dL | 24 Hours Post Exercise Automated Mode | 1.72 Percent of time | Standard Deviation 2.32 |
| Treatment | Percent of Time < 70 mg/dL | 24 Hours Post Exercise HPt-60 | 2.00 Percent of time | Standard Deviation 3.01 |
| Treatment | Percent of Time < 70 mg/dL | 24 Hours Post Exercise HPt-30 | 1.78 Percent of time | Standard Deviation 3.8 |
Other Pre-specified
Percent of Time in Range 70-180 mg/dL
Measure of device effectiveness
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Percent of Time in Range 70-180 mg/dL | 12 Hours Post Exercise HPt-30 | 71.3 Percent of time | Standard Deviation 22.1 |
| Treatment | Percent of Time in Range 70-180 mg/dL | During Exercise Automated Mode | 88.9 Percent of time | Standard Deviation 16.4 |
| Treatment | Percent of Time in Range 70-180 mg/dL | During Exercise HPt-60 | 90.4 Percent of time | Standard Deviation 14.3 |
| Treatment | Percent of Time in Range 70-180 mg/dL | During Exercise HPt-30 | 89.5 Percent of time | Standard Deviation 20.8 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 4-Hours Post Exercise Automated Mode | 69.4 Percent of time | Standard Deviation 26.9 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 4-Hours Post Exercise HPt-60 | 66.9 Percent of time | Standard Deviation 24.8 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 4-Hours Post Exercise HPt-30 | 66.6 Percent of time | Standard Deviation 27.6 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 12 hours Post Exercise Automated Mode | 67.3 Percent of time | Standard Deviation 23.8 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 12 Hours Post Exercise HPt-60 | 70.1 Percent of time | Standard Deviation 20.2 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 24 Hours Post Exercise Automated Mode | 74.2 Percent of time | Standard Deviation 17.1 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 24 Hours Post Exercise HPt-60 | 74.7 Percent of time | Standard Deviation 17.1 |
| Treatment | Percent of Time in Range 70-180 mg/dL | 24 Hours Post Exercise HPt-30 | 75.1 Percent of time | Standard Deviation 16.6 |
Other Pre-specified
Standard Deviation (of Glucose)
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: Automated Mode compared to HypoProtect use during 70-minute exercise session and at 4-, 12-, and 24-hours post-exercise
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Standard Deviation (of Glucose) | During Exercise Automated Mode | 24.8 mg/dL | Standard Deviation 13.8 |
| Treatment | Standard Deviation (of Glucose) | During Exercise HPt-60 | 19.8 mg/dL | Standard Deviation 11.6 |
| Treatment | Standard Deviation (of Glucose) | During Exercise HPt-30 | 19.1 mg/dL | Standard Deviation 11.3 |
| Treatment | Standard Deviation (of Glucose) | 4 Hours Post Exercise Automated Mode | 39.7 mg/dL | Standard Deviation 17.7 |
| Treatment | Standard Deviation (of Glucose) | 4 Hours Post Exercise HPt-60 | 37.2 mg/dL | Standard Deviation 16.1 |
| Treatment | Standard Deviation (of Glucose) | 4 Hours Post Exercise HPt-30 | 42.1 mg/dL | Standard Deviation 24.2 |
| Treatment | Standard Deviation (of Glucose) | 12 Hours Post Exercise Automated Mode | 45.4 mg/dL | Standard Deviation 19 |
| Treatment | Standard Deviation (of Glucose) | 12 Hours Post Exercise HPt-60 | 47.0 mg/dL | Standard Deviation 20 |
| Treatment | Standard Deviation (of Glucose) | 12 Hours Post Exercise HPt-30 | 46.3 mg/dL | Standard Deviation 19 |
| Treatment | Standard Deviation (of Glucose) | 24 Hours Post Exercise Automated Mode | 44.2 mg/dL | Standard Deviation 15.3 |
| Treatment | Standard Deviation (of Glucose) | 24 Hours Post Exercise HPt-60 | 45.1 mg/dL | Standard Deviation 17.5 |
| Treatment | Standard Deviation (of Glucose) | 24 Hours Post Exercise HPt-30 | 46.7 mg/dL | Standard Deviation 16.2 |