The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes

Not Applicable

Completed

Conditions: Type 1 Diabetes

Interventions: Device: Standard Care (SC)

Registration Number: NCT04796779

Lead Sponsor: Marc Breton

Brief 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.

Detailed Description: Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system.

This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic.

A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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 <6 years old
Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study.

• Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
Total daily insulin dose (TDD) at least 5 U/day
Body weight at least 20 lbs.
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
Parent/guardian proficient in reading and writing English.

Exclusion Criteria

Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
Hemophilia or any other bleeding disorder
History of >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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SC Group	Standard Care (SC)	Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26).

Primary Outcome Measures

Name	Time	Method
Time in Range	13 weeks	Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM

Secondary Outcome Measures

Name	Time	Method
CGM-measured Mean Glucose	13 weeks	Average glucose value measured by CGM
HbA1c at 13 Weeks	13 weeks	HbA1c at 13 weeks
CGM-measured Percent Below 70 mg/dL	13 weeks	Percentage of time with glucose below 70 mg/dL as measured by CGM
CGM-measured Percent Above 250 mg/dL	13 weeks	Percentage of time with a glucose above 250 mg/dL as measured by CGM
CGM-measured Percent Below 54 mg/dL	13 weeks	Percentage of time with glucose below 54 mg/dL as measured by CGM

Trial Locations

Locations (3): Stanford University
🇺🇸
Stanford, California, United States
Barbara Davis Center, University of Colorado
🇺🇸
Aurora, Colorado, United States
University of Virginia Center for Diabetes Technology
🇺🇸
Charlottesville, Virginia, United States