N/A
Completed N=36
Prepivotal Omnipod Horizon™ Automated Glucose Control System
Source: ClinicalTrials.gov NCT04176731 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Proportion of Subjects With Severe Hypoglycemia — 0 Participants
Summary
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and outpatient setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Severe Hypoglycemia |
— | — |
| PRIMARY Proportion of Subjects With Diabetic Ketoacidosis (DKA) |
— | — |
| PRIMARY Percentage of Time in Range 70-180 mg/dL During Target Blood Glucose Challenge Days of Hybrid Closed Loop Phase (Days 1-9) and Standard Therapy Period (14 Days) |
58; 62.2; 59.2; 71.2; 58.3; 64.4 | — |
| PRIMARY Percentage of Time in Range 70-180 mg/dL During Non-Challenge Days of Hybrid Closed Loop Phase (Days 10-14) and Standard Therapy Period (14 Days) |
58.0; 67.2; 59.2; 72.8; 58.3; 68.7 | — |
| PRIMARY Percentage of Time in Range 70-180 mg/dL During Overall (Days 1-14) and Standard Therapy Period (14 Days) |
58.0; 63.9; 59.2; 71.1; 58.3; 65.8 | — |
| SECONDARY Mean Glucose |
172.8; 168.4; 165.8; 163.0; 171.2; 167.0 | — |
| SECONDARY Time in Range 70-180 mg/dL |
58.0; 63.9; 59.2; 71.1; 58.3; 65.8 | — |
| SECONDARY Time in Range 70-140 mg/dL |
35.7; 33.2; 37.8; 35.3; 36.2; 33.8 | — |
| SECONDARY Percentage of Time >180 mg/dL |
39.5; 35.1; 36.6; 27.8; 38.8; 33.3 | — |
| SECONDARY Percentage of Time ≥250 mg/dL |
14.6; 9.1; 12.6; 6.5; 14.1; 8.5 | — |
| SECONDARY Percentage of Time ≥300 mg/dL |
5.6; 2.4; 4.6; 2.0; 5.4; 2.3 | — |
| SECONDARY Percentage of Time <70 mg/dL |
2.4; 1.0; 4.2; 0.5; 2.9; 0.9 | — |
| SECONDARY Percentage of Time <54 mg/dL |
0.5; 0.1; 1.1; 0.1; 0.6; 0.1 | — |
| SECONDARY Standard Deviation of Glucose (mg/dL) |
62.9; 53.4; 60.5; 45.0; 63.3; 52.3 | — |
| SECONDARY Coefficient of Variation |
36.3; 31.6; 36.5; 27.3; 36.9; 31.2 | — |
| SECONDARY Glucose Management Indicator (GMI) Based on Overall Mean Glucose |
7.4; 7.3; 7.3; 7.2; 7.4; 7.3 | — |
| SECONDARY Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time |
97.3; 2.1 | — |
| SECONDARY Total Daily Insulin (TDI) (Units, Units/kg) |
39.5; 37.0 | — |
| SECONDARY Total Daily Basal Insulin (Units, Units/kg) |
20.7; 17.5 | — |
| SECONDARY Total Daily Bolus Insulin (Units, Units/kg) |
19.4; 19.5 | — |
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 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 (NCT04176731). 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.