Artificial Pancreas - Adolescent Physiology & Psychology Longitudinal Evaluation

NCT04510506 | Completed DMC FDA Device

• 2 other identifiers: 1900881R01DK124886-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study designed to assess changes in control of Type 1 Diabetes in pubertal adolescents over a two year period. There are two arms/substudies, the first being a longitudinal randomized controlled trial and the second an observational study.

Conditions

Type 1 Diabetes

Keywords

Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Insulin Pump; Closed Loop Control; Multiple Daily Injections (MDI); Control-IQ Technology; Triple Tracer Study; Glycemic Only

Outcome Measures

Primary Outcomes (2)

• Randomized substudy: The 24-month HbA1c between AP system and Usual Care+CGM groups, performed as regression, adjusted for baseline HbA1c.

  Measure of HbA1c

  2 years

• Combined Triple Label Surveillance and Randomized substudies: Change in insulin sensitivity (Si) over time

  Changes in Si (from triple-label, mixed-meal test) over time between baseline and 24 months

  Baseline, 12 months, 24 months

Secondary Outcomes (92)

• Triple Label tracer (both substudies): Change in Endogenous Glucose Production (EGP)

  24 months

• Triple Label tracer (both substudies): Change in Rate of Glucose Appearance (Ra)

  24 months

• Triple Label tracer (both substudies): Change in Rate of Glucose Disappearance (Rd)

  24 months

• Randomized Substudy: Comparison of Glycemic Control (below also) - Time in range, overall

  2 years

• Glycemic Control - Time in range, months 0-6

  6 months

Study Arms (3)

Randomized substudy: Artificial Pancreas Therapy

EXPERIMENTAL

Participants will use a study assigned Tandem t:slim X2 with Control-IQ Technology.for two years.

Device: Artificial Pancreas (AP)

Randomized substudy: Usual Care + CGM

NO INTERVENTION

Participant will use their usual diabetes care along with a study CGM.

Triple Label Surveillance substudy (observational arm)

NO INTERVENTION

Participants will remain on own baseline diabetes management (e.g. automated insulin delivery system, non-AID pump, MDI)

Interventions

Artificial Pancreas (AP) DEVICE

The AP system used in this trial is the Tandem t:slim insulin pump with Control-IQ Technology. This system is FDA approved for use starting at age 14 years.

Randomized substudy: Artificial Pancreas Therapy

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 11 to \<13 years (at time of enrollment) with a parent/guardian (18+ yo) who is willing to participate with the child
• At least Tanner 2 pubic hair (boys), Tanner 2 breast development (girls)
• HbA1c \<10 clinically obtained within the last 6 weeks; if the participant is unable to go to the laboratory or clinic because of stay-at-home orders, the entry hemoglobin A1c level can be assessed via outside laboratory (e.g. LabCorp), home HbA1c device, recent clinically-obtained HbA1c in past month..
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
• Currently using insulin for at least six months
• Both prior pump and MDI users will use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
• Access to internet and willingness to upload data during the study as needed
• For females, not currently known to be pregnant or breastfeeding
• If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• 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, if randomized to the Control-IQ group.
• Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
• An understanding and willingness to follow the protocol and signed informed consent
• Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment.

You may not qualify if:

• Hemoglobin A1c \>10% clinically obtained within the past 6 weeks
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Severe renal impairment, end-stage renal disease, or dialysis
• Inpatient psychiatric treatment in the past six months
• Presence of a known adrenal disorder
• Abnormal liver function test results (Transaminase\>2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function
• Uncontrolled thyroid disease
• Concurrent use of any non-insulin glucose-lowering agent.
• Hemophilia or any other bleeding disorder.
• 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 being treated for a seizure disorder
• Planned surgery during study duration
• Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator
• Tandem Diabetes Care, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Mark D. DeBoer, MD, MSc, MCR

  UVA Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a longitudinal randomized controlled study designed to assess changes in control of Type 1 Diabetes in pubertal adolescents over a two year period.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 12, 2020
• Study Start: November 19, 2020
• Primary Completion: October 23, 2025
• Study Completion: October 24, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Generally will be available after publications completed.
• Access Criteria: No restrictions for access.

Locations

US (1)