N/A
N=102
The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04796779 ↗Enrolled (actual)
102
Serious AEs
4.9%
Results posted
Jun 2023
Primary outcome: Primary: Time in Range — 56.7; 54.9; 69.3; 55.9 Percent of time — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tandem t:slim X2 with Control-IQ Technology Pro (Device); Standard Care (SC) (Device); Tandem t:slim X2 with Control-IQ Technology V1.5 (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Marc Breton
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range |
56.7; 54.9; 69.3; 55.9 | <0.001 sig |
| SECONDARY CGM-measured Percent Above 250 mg/dL |
14.8; 16.0; 8.4; 15.0 | <0.001 sig |
| SECONDARY CGM-measured Mean Glucose |
173; 176; 155; 174 | <0.001 sig |
| SECONDARY HbA1c at 13 Weeks |
7.5; 7.7; 7.0; 7.5 | <0.001 sig |
| SECONDARY CGM-measured Percent Below 70 mg/dL |
3.0; 2.7; 3.0; 3.0 | 0.57 |
| SECONDARY CGM-measured Percent Below 54 mg/dL |
0.6; 0.5; 0.6; 0.5 | — |
Summary
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
- 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 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
- 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 (specified in the study procedure manual)
- Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Employed by, or having immediate family members employed by Tandem Diabetes Care, 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 (NCT04796779). 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.