The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
3 other identifiers
interventional
102
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
12 months
February 15, 2021
April 10, 2023
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in Range
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
13 weeks
Secondary Outcomes (5)
CGM-measured Percent Above 250 mg/dL
13 weeks
CGM-measured Mean Glucose
13 weeks
HbA1c at 13 Weeks
13 weeks
CGM-measured Percent Below 70 mg/dL
13 weeks
CGM-measured Percent Below 54 mg/dL
13 weeks
Other Outcomes (46)
Percent Above 180 mg/dL
13 weeks
Percent in Range 70-140 mg/dL
13 weeks
Glucose Variability Measured With the Coefficient of Variation (CV)
13 weeks
- +43 more other outcomes
Study Arms (2)
CLC Group
EXPERIMENTALParticipants 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 intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26).
SC Group
ACTIVE COMPARATORParticipants 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).
Interventions
The Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.
Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).
The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marc Bretonlead
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Jaeb Center for Health Researchcollaborator
- Tandem Diabetes Care, Inc.collaborator
Study Sites (3)
Stanford University
Stanford, California, 94304, United States
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045, United States
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
Related Publications (2)
Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
PMID: 36920756BACKGROUNDBeck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.
PMID: 37067353DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc Breton, PhD
- Organization
- University of Virginia
Study Officials
- STUDY DIRECTOR
John Lum, MS
Jaeb Center for Health Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 15, 2021
First Posted
March 15, 2021
Study Start
April 21, 2021
Primary Completion
April 12, 2022
Study Completion
July 31, 2022
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Generally, data will be made available after the primary publications of each study.
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.