N/A
Completed N=25
Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes
Source: ClinicalTrials.gov NCT04878120 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Low Blood Glucose Index (LBGI) — 2.87; 3.19; 1.1; 1.70 score on a scale — p=0.733
Summary
The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Blood Glucose Index (LBGI) |
2.87; 3.19; 1.1; 1.70 | 0.733 |
| SECONDARY Percentage of Time Spent Below 70 mg/dL |
10.33; 12.08; 2.31; 5.00 | 0.824 |
| SECONDARY Percentage of Time Spent in 70-180 mg/dL |
83.16; 78.16; 81.47; 85.44 | 0.402 |
| SECONDARY Percentage of Time Spent Above 180 mg/dL |
6.51; 9.76; 16.22; 9.56 | 0.300 |
| SECONDARY High Blood Glucose Index (HBGI) |
1.64; 3.51; 4.10; 1.85 | 0.168 |
| SECONDARY CGM Coefficient of Variation |
25.36; 25.74; 24.01; 21.74 | 0.476 |
| SECONDARY Total Amount of Carbohydrate Administered as Rescue Treatments |
29.75; 37.45; 11.54; 20.41 | 0.914 |
Eligibility Criteria
Inclusion Criteria
- Age ≥12 and 10% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately between 100 and 240 mg/dL
- History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently breastfeeding or planning to breastfeed
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- History of cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted)
- Treatment with any non-insulin glucose-lowering agent (metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an insulin delivery mechanism that is not downloadable by the participant or study team
- Known contact with COVID-positive individual within 14 days of any study admission without negative follow-up COVID-19 Polymerase Chain Reaction (PCR) test performed 3-5 days after the date of exposure
- Symptoms of COVID-19 (e.g., fever, shortness of breath, unexpected loss of taste or smell) developed within 14 days of any study admission
- A positive COVID-19 test within 14 days of any study admission or during study admission participation
- Not being fully vaccinated at the time of the first camp admission (according to Center for Disease Control (CDC) guidelines a person is intended to be fully vaccinated after two weeks from either the second dose of the Pfizer or Moderna vaccine, or the single dose of the Johnson & Johnson vaccine)
Data sourced from ClinicalTrials.gov (NCT04878120). 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.