N/A
Completed N=240
Pivotal Omnipod Horizon™ Automated Glucose Control System
Source: ClinicalTrials.gov NCT04196140 ↗Enrolled (actual)
240
Serious AEs
5.4%
Results posted
May 2024
Primary outcomePrimary: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) — .004 events per person month
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Severe Hypoglycemia (Events Per Person Months) |
.004 | — |
| PRIMARY Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) |
.001 | — |
| PRIMARY Glycated Hemoglobin (A1C) |
7.4; 6.7; 7.4; 6.9; 6.8; 7.1 | — |
| PRIMARY Time in Range 70-180 mg/dL |
58.6; 68.8; 60.1; 78.1; 59.0; 71.2 | — |
| SECONDARY Percent of Time >180 mg/dL |
39.0; 29.5; 31.3; 36.8; 20.7; 22.0 | — |
| SECONDARY Percent of Time <70 mg/dL |
2.4; 1.66; 3.11; 1.17; 2.57; 1.53 | — |
| SECONDARY Glycated Hemoglobin (A1C) |
7.4; 6.7; 7.4; 6.9; 6.8; 7.1 | — |
| SECONDARY Mean Glucose |
117.6; 123.2; 119.7; 150.6; 156.9; 167.2 | — |
| SECONDARY Percent of Time in Range 70-180 mg/dL |
88.9; 90.4; 89.5; 69.4; 66.9; 66.6 | — |
| SECONDARY Percent of Time in Range 70-140 mg/dL |
36.0; 43.7; 42.6; 38.2; 52.8; 51.9 | — |
| SECONDARY Percent of Time ≥ 250 mg/dL |
0.3; 0.0; 0.0; 6.3; 4.5; 12.0 | — |
| SECONDARY Percent of Time ≥ 300 mg/dL |
0.0; 0.0; 0.0; 1.4; 1.8; 5.3 | — |
| SECONDARY Percent of Time < 70 mg/dL |
6.52; 5.12; 5.88; 2.72; 2.17; 1.68 | — |
| SECONDARY Percent of Time < 54 mg/dL |
1.40; 0.52; 0.37; 0.38; 0.60; 0.26 | — |
| SECONDARY Standard Deviation (of Glucose) |
24.8; 19.8; 19.1; 39.7; 37.2; 42.1 | — |
| SECONDARY Percent Coefficient of Variation (of Glucose) |
36.1; 34.6; 35.4; 34.9; 30.3; 32.1 | — |
| SECONDARY Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time |
95; 4.2; 93.6; 4.9 | — |
| SECONDARY Percent Glucose Management Indicator (% GMI) |
7.44; 7.12; 7.19; 7.32; 6.87; 6.92 | — |
| SECONDARY Total Daily Insulin (TDI) (Units) |
41.7; 42.1; 46.3 | — |
| SECONDARY Total Daily Insulin (TDI) (Units/kg) |
0.72; 0.75; 0.81 | — |
| SECONDARY Total Daily Basal Insulin (Units) |
19.7; 21.4; 24.3 | — |
| SECONDARY Total Daily Basal Insulin (Units/kg) |
0.33; 0.38; 0.43 | — |
| SECONDARY Total Daily Bolus Insulin (Units) |
21.8; 20.7; 22.0 | — |
| SECONDARY Total Daily Bolus Insulin (Units/kg) |
0.39; 0.37; 0.38 | — |
| SECONDARY Body Mass Index (BMI) (kg/m^2) |
22.8; 23.0; 23.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age at time of consent/assent 6-70 years
- Subjects aged 50 years old or with diabetes duration >20 years, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- 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)
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04196140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.