N/A
N=32
The Pediatric Artificial Pancreas Automated Initialization Trial
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT06017089 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Sep 2025
Primary outcome: Primary: Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) — 0.3; 0.3 percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AI-based Advisor system (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Marc Breton
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) |
0.3; 0.3 | — |
| PRIMARY Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) |
13; 9 | — |
| PRIMARY Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) |
63; 70 | — |
| PRIMARY Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) |
168; 157 | — |
| PRIMARY Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) |
13; 9 | — |
| PRIMARY Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) |
2; 1.7 | — |
| PRIMARY Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) |
0.3; 0.3 | — |
| SECONDARY CGM Measured Time in Range |
42; 47 | — |
| SECONDARY CGM Measured (a) |
35; 29 | — |
| SECONDARY CGM Measured (b) |
5.9; 3.3 | — |
| SECONDARY CGM Measured (c) |
0.7; 0.6 | — |
| SECONDARY CGM Measured (d) |
64; 59 | — |
| SECONDARY CGM Measured (e) |
38; 37 | — |
| SECONDARY CGM Measured (f) |
8.8; 6.8 | — |
| SECONDARY CGM Measured (g) |
0.6; 0.6 | — |
| SECONDARY CGM Measured (h) |
1.9; 1.1 | — |
| SECONDARY CGM Measured (i) |
0.6; 0.4 | — |
| SECONDARY Binary Outcome 1 |
13 | — |
| SECONDARY Binary Outcome 2 |
9 | — |
| SECONDARY Binary Outcome 3 |
10; 13 | — |
| SECONDARY Total Daily Insulin |
0.59; 0.66 | — |
| SECONDARY Basal Insulin |
39; 38 | — |
Summary
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month
- Familiarity and use of a carbohydrate ratio for meal boluses
- Age ≥2 and 1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
- History of >1 diabetic ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
- History of chronic renal disease or currently on hemodialysis
- History of adrenal insufficiency
- Hypothyroidism that is not adequately treated in the opinion of the investigator
- Use of oral or injectable steroids within the last 8 weeks
- Known, ongoing adhesive intolerance
- Plans to receive blood transfusions or erythropoietin injections during the course of the study
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Data sourced from ClinicalTrials.gov (NCT06017089). 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.