Type 1 Diabetes
Conditions
Keywords
T1D, Omnipod
Brief summary
Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
Detailed description
The study schedule consists of two outpatient phases: 1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by; 2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2) Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study. Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator. After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
Interventions
Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
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
2 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age at time of consent/assent 2-70 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. Must be a current Omnipod user, or have used an Omnipod in the past 5. Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol 6. Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra 7. Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality 8. Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses 9. Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses 10. Willing to wear the system continuously throughout the study 11. For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C \<10% 12. Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App) 13. Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria) 14. 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 subjects aged \< 18 years per State requirements. 15. For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.
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 or infusion set failure 4. Plans to receive blood transfusion over the course of the study 5. Currently diagnosed with anorexia nervosa or bulimia 6. Acute or chronic kidney disease or currently on hemodialysis 7. History of adrenal insufficiency 8. Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study 9. Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement 10. Plans to use insulin other than U-100 insulin intended for use in the study device during the study 11. Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide) 12. 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 13. Clinical signs of hypothyroidism and hyperthyroidism 14. 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) 15. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause. 16. 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 |
|---|---|---|
| Percentage of Time <70 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time >180 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time ≥ 250 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time ≥ 300 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time in Range 70-180 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time <70 mg/dL | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | Glucose metric from continuous glucose monitoring system (CGM) |
| Mean Glucose | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time in Range 70-140 mg/dL | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | Glucose metric from continuous glucose monitoring system (CGM) |
| Standard Deviation | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) |
| Coefficient of Variation | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) |
| Percentage of Time >180 mg/dL | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall | Glucose metric from continuous glucose monitoring system (CGM) |
| Percentage of Time <54 mg/dL | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) | Glucose metric from continuous glucose monitoring system (CGM) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omnipod Horizon™ Automated Glucose Control System All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days.
Omnipod Horizon™ Automated Glucose Control System: Omnipod Horizon™ Automated Glucose Control System use in Manual Mode | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Omnipod Horizon™ Automated Glucose Control System |
|---|---|
| Age, Continuous | 26.9 years STANDARD_DEVIATION 15.4 |
| BMI | 23.8 kg/m^2 STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Phase 1 | 32.1 Percent Time in Range | Standard Deviation 15.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Phase 2 | 34.0 Percent Time in Range | Standard Deviation 16 |
Primary
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Phase 1 | 2.8 Percent Time in Range | Standard Deviation 2.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Phase 2 | 2.1 Percent Time in Range | Standard Deviation 2 |
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 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Day Time Phase 1 | 34.6 Percent coefficient of variation | Standard Deviation 6.6 |
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Day Time Phase 2 | 33.5 Percent coefficient of variation | Standard Deviation 6.7 |
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Night Time Phase 1 | 31.0 Percent coefficient of variation | Standard Deviation 7.1 |
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Night Time Phase 2 | 30.0 Percent coefficient of variation | Standard Deviation 8 |
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Overall Phase 1 | 34.3 Percent coefficient of variation | Standard Deviation 5.8 |
| Omnipod Horizon™ Automated Glucose Control System | Coefficient of Variation | Overall Phase 2 | 33.4 Percent coefficient of variation | Standard Deviation 6.3 |
Secondary
Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Phase 2 | 163.3 mg/dL | Standard Deviation 23.6 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Phase 1 | 158.7 mg/dL | Standard Deviation 21.3 |
Secondary
Mean Glucose
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Day Time Phase 1 | 150.1 mg/dL | Standard Deviation 18.1 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Day Time Phase 2 | 152.8 mg/dL | Standard Deviation 20.7 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Night Time Phase 1 | 151.4 mg/dL | Standard Deviation 27.7 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Night Time Phase 2 | 155.6 mg/dL | Standard Deviation 28.3 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Overall Phase 1 | 150.4 mg/dL | Standard Deviation 18.9 |
| Omnipod Horizon™ Automated Glucose Control System | Mean Glucose | Overall Phase 2 | 153.5 mg/dL | Standard Deviation 20.3 |
Secondary
Percentage of Time >180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Night Time Phase 1 | 26.9 Percent Time in Range | Standard Deviation 18.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Day Time Phase 1 | 25.9 Percent Time in Range | Standard Deviation 13.5 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Day Time Phase 2 | 26.8 Percent Time in Range | Standard Deviation 14.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Night Time Phase 2 | 26.9 Percent Time in Range | Standard Deviation 19 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Overall Phase 1 | 26.2 Percent Time in Range | Standard Deviation 13.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time >180 mg/dL | Overall Phase 2 | 26.8 Percent Time in Range | Standard Deviation 14 |
Secondary
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Phase 1 | 8.2 Percent Time in Range | Standard Deviation 6.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Phase 2 | 9.7 Percent Time in Range | Standard Deviation 10.3 |
Secondary
Percentage of Time ≥ 250 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Day Time Phase 1 | 6.3 Percent Time in Range | Standard Deviation 4.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Day Time Phase 2 | 7.0 Percent Time in Range | Standard Deviation 8.3 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Night Time Phase 1 | 6.3 Percent Time in Range | Standard Deviation 8.3 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Night Time Phase 2 | 8.2 Percent Time in Range | Standard Deviation 11.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Overall Phase 1 | 6.3 Percent Time in Range | Standard Deviation 5.1 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 250 mg/dL | Overall Phase 2 | 7.3 Percent Time in Range | Standard Deviation 7.4 |
Secondary
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Phase 1 | 2.0 Percent Time in Range | Standard Deviation 2.6 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Phase 2 | 2.6 Percent Time in Range | Standard Deviation 3.7 |
Secondary
Percentage of Time ≥ 300 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Day Time Phase 1 | 1.4 Percent Time in Range | Standard Deviation 1.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Day Time Phase 2 | 1.9 Percent Time in Range | Standard Deviation 2.8 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Night Time Phase 1 | 1.5 Percent Time in Range | Standard Deviation 3.4 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Night Time Phase 2 | 1.8 Percent Time in Range | Standard Deviation 3.5 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Overall Phase 1 | 1.4 Percent Time in Range | Standard Deviation 1.8 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time ≥ 300 mg/dL | Overall Phase 2 | 1.8 Percent Time in Range | Standard Deviation 2.3 |
Secondary
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Day Time Phase 1 | 0.5 Percent Time in Range | Standard Deviation 0.8 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Day Time Phase 2 | 0.3 Percent Time in Range | Standard Deviation 0.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Night Time Phase 1 | 0.3 Percent Time in Range | Standard Deviation 0.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Night Time Phase 2 | 0.4 Percent Time in Range | Standard Deviation 0.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Overall Phase 1 | 0.4 Percent Time in Range | Standard Deviation 0.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Overall Phase 2 | 0.4 Percent Time in Range | Standard Deviation 0.5 |
Secondary
Percentage of Time <54 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Phase 1 | 0.5 Percent Time in Range | Standard Deviation 1 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <54 mg/dL | Phase 2 | 0.3 Percent Time in Range | Standard Deviation 0.7 |
Secondary
Percentage of Time <70 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Day Time Phase 1 | 2.9 Percent Time in Range | Standard Deviation 2.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Day Time Phase 2 | 2.7 Percent Time in Range | Standard Deviation 2.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Night Time Phase 1 | 2.8 Percent Time in Range | Standard Deviation 4.1 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Night Time Phase 2 | 2.7 Percent Time in Range | Standard Deviation 3.7 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Overall Phase 1 | 2.9 Percent Time in Range | Standard Deviation 2.3 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time <70 mg/dL | Overall Phase 2 | 2.7 Percent Time in Range | Standard Deviation 2 |
Secondary
Percentage of Time in Range 70-140 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Day Time Phase 1 | 47.4 Percent Time in Range | Standard Deviation 13.9 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Day Time Phase 2 | 45.8 Percent Time in Range | Standard Deviation 15.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Night Time Phase 1 | 46.5 Percent Time in Range | Standard Deviation 18.1 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Night Time Phase 2 | 42.1 Percent Time in Range | Standard Deviation 18.5 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Overall Phase 1 | 47.2 Percent Time in Range | Standard Deviation 13.8 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-140 mg/dL | Overall Phase 2 | 44.9 Percent Time in Range | Standard Deviation 14.8 |
Secondary
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Phase 1 | 65.1 Percent Time in Range | Standard Deviation 15.4 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Phase 2 | 63.8 Percent Time in Range | Standard Deviation 15.7 |
Secondary
Percentage of Time in Range 70-180 mg/dL
Glucose metric from continuous glucose monitoring system (CGM)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Day Time Phase 1 | 71.1 Percent Time in Range | Standard Deviation 13.4 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Day Time Phase 2 | 70.6 Percent Time in Range | Standard Deviation 14.3 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Night Time Phase 1 | 70.3 Percent Time in Range | Standard Deviation 17.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Night Time Phase 2 | 70.4 Percent Time in Range | Standard Deviation 18.8 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Overall Phase 1 | 70.9 Percent Time in Range | Standard Deviation 13.2 |
| Omnipod Horizon™ Automated Glucose Control System | Percentage of Time in Range 70-180 mg/dL | Overall Phase 2 | 70.6 Percent Time in Range | Standard Deviation 14.1 |
Secondary
Standard Deviation
Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD)
Time frame: Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Day Time Phase 1 | 52.1 mg/dL | Standard Deviation 12.2 |
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Day Time Phase 2 | 51.4 mg/dL | Standard Deviation 12.8 |
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Night Time Phase 1 | 47.3 mg/dL | Standard Deviation 15.6 |
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Night Time Phase 2 | 47.2 mg/dL | Standard Deviation 16.7 |
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Overall Phase 1 | 51.9 mg/dL | Standard Deviation 12.1 |
| Omnipod Horizon™ Automated Glucose Control System | Standard Deviation | Overall Phase 2 | 51.6 mg/dL | Standard Deviation 12.8 |