N/A
Completed N=80
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
Source: ClinicalTrials.gov NCT04476472 ↗Enrolled (actual)
80
Serious AEs
5.0%
Results posted
Feb 2024
Primary outcomePrimary: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) — 0; 0.0007 events per person months
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) |
0; 0.0007 | — |
| PRIMARY Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) |
0; 0.0007 | — |
| PRIMARY Glycated Hemoglobin (A1C) |
7.4; 6.9; 7.0; 7.1; 6.9; 7.0 | — |
| PRIMARY Time in Range 70-180 mg/dL |
56.9; 63.7; 63.5; 58.2; 81.0; 78.2 | — |
| SECONDARY Glycated Hemoglobin (A1C) |
7.4; 6.9; 7.0; 7.1; 6.9; 7.0 | — |
| SECONDARY Percent of Time in Range 70-140 mg/dL |
36.2; 41.3; 41.2; 36.7; 57.7; 53.9 | — |
| SECONDARY Percent of Time > 180 mg/dL |
39.7; 33.7; 33.7; 38.4; 16.9; 19.7 | — |
| SECONDARY Percent of Time ≥ 250 mg/dL |
15.4; 11.0; 11.5; 13.0; 3.9; 5.1 | — |
| SECONDARY Percent of Time ≥ 300 mg/dL |
6.5; 3.9; 4.4; 4.3; 1.2; 1.8 | — |
| SECONDARY Percent of Time < 70 mg/dL |
3.44; 2.57; 2.79; 3.41; 2.13; 2.06 | — |
| SECONDARY Percent of Time < 54 mg/dL |
0.80; 0.50; 0.59; 0.85; 0.39; 0.49 | — |
| SECONDARY Mean Glucose |
172.2; 163.0; 163.6; 168.1; 140.7; 145.7 | — |
| SECONDARY Standard Deviation |
66.1; 62.2; 63.4; 58.0; 45.5; 48.8 | — |
| SECONDARY Coefficient of Variation |
38.6; 38.0; 38.6; 34.7; 32.1; 33.2 | — |
| SECONDARY Percentage of Time in Hybrid Closed-loop as Proportion of Overall Device Usage Time |
96.8; 2.8; 95.5; 3.2 | — |
| SECONDARY Glucose Management Indicator (GMI) |
7.43; 7.21; 7.22; 7.33; 6.68; 6.79 | — |
| SECONDARY Total Daily Insulin (TDI) (Units) |
13.7; 14.1; 16.4 | — |
| SECONDARY Total Daily Insulin (TDI) (Units/kg) |
0.69; 0.71; 0.80 | — |
| SECONDARY Total Daily Basal Insulin (Units) |
5.6; 6.4; 7.7 | — |
| SECONDARY Total Daily Basal Insulin (Units/kg) |
0.28; 0.32; 0.38 | — |
| SECONDARY Total Daily Bolus Insulin (Units) |
8.1; 7.7; 8.7 | — |
| SECONDARY Total Daily Bolus Insulin (Units/kg) |
0.41; 0.39; 0.42 | — |
| SECONDARY Body Mass Index (BMI) (kg/m^2) |
16.7; 16.7; 16.9 | — |
Eligibility Criteria
Inclusion Criteria
- Age at time of consent 2.0-5.9 years
- Living with parent/legal guardian
- Diagnosed with type 1 diabetes. Diagnosis is based on investigator's clinical judgment
- Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities
- Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol
- Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study
- Willing to wear the system continuously throughout the study
- Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%
- A1C <10% at screening visit
- Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase
- Subject and/or parent/guardian is able to read and speak English fluently
- Has a parent/legal guardian willing and able to sign the ICF.
Exclusion Criteria
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis
- Diagnosed with sickle cell disease
- Diagnosed with hemophilia or any other bleeding disorders
- Plans to receive blood transfusion over the course of the study
- Clinical evidence of acute or chronic kidney disease (e.g. estimated GFR < 45) or currently on hemodialysis
- History of adrenal insufficiency
- 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
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study
- Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
- Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period
- 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 (NCT04476472). 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.