Type 1 DiabetesAP APPLENCT04510506
Artificial Pancreas - Adolescent Physiology & Psychology Longitudinal Evaluation
A study testing Artificial Pancreas (AP) in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Artificial Pancreas (AP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
- Contact with primary diabetes physician to discuss study details and the participant's care, with study team continuing to feel that the participant is appropriate for study inclusion.
Who cannot join
- 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
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- 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)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- Use of an insulin delivery mechanism that is not downloadable by the subject or study team
- (Randomized substudy only) Current use of an automated insulin delivery system (besides LGS and PLGS) such as Medtronic 670G, Control-IQ or DIY system (or unwillingness to discontinue automated insulin delivery for three months before enrollment and the duration of the trial).
- Having a family member(s) employed by Tandem Diabetes Care, Inc. or Dexcom, Inc.
- Current enrollment in another clinical trial, unless approved by the investigator of both studies or if clinical trial is a non-interventional registry trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22904
About this study
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.
Read the detailed description
The investigators will recruit adolescents with type 1 diabetes age 11-<13 years and one parent to participate in this 24-month study. While this is admittedly a long enrollment time, study commitments following enrollment will be limited to three in-person or video visits at yearly intervals and one virtual or in-person device training session to improve adherence. Participants must be pubertal, as puberty appears to contribute significantly to the insulin resistance that is likely related to worsened blood glucose control. Pubertal assessments will occur at yearly intervals.
The first of the two arms/substudies ("Randomized" substudy) is a longitudinal randomized controlled trial for which participants will be randomized to either continue their current diabetes therapy (with the addition of use of a Dexcom CGM, forming the "Usual Care+CGM" Control Group; this includes both adolescents using non-automated insulin delivery (AID) insulin pumps or multiple daily injections [MDI]). The Experimental Group will use an AP system (Tandem's Control-IQ system) during the two-year duration of the study. The primary outcome of the Randomized substudy will be HbA1c between intervention groups at the 24-month visit.
The second arm/substudy ("Triple Label Surveillance" substudy) is an observational study. Both arms/substudies perform a "Triple Label" mixed meal study assessing glucose flux and insulin resistance that requires visits to the Clinical Research Unit. All participants will undergo a Triple-Labeled Glucose Assessment at months 0, 12 and 24. This assessment evaluates the degree of insulin resistance including in the hepatic and peripheral compartments. During Visit 2, all participants (for both the Triple Label sub-study and the Glycemia-Only sub-study) will complete multiple questionnaires assessing aspects of adolescent psychology and sociology. HbA1c will also be collected using a local lab. The primary outcome of the study overall (combined Triple Label Surveillance and Randomized substudies) is the change in insulin resistance between baseline and the 24-month visit.
CGM glucose data will be collected continuously via remote connection during the entire study. At months 6 and 18, participants will be contacted to obtain insulin management information and will have HbA1c measures assessed at a local clinic or laboratory. Additional scheduled phone calls will occur in the month before the in-person study visits to request HbA1c and confirm body composition/Triple-Labeled Glucose Assessment scheduling and discuss use of CGM and activity tracker. Participants will be contacted in the event of insufficient CGM or AP system use. For the Randomized substudy, in the Eperimental Group, insufficient use is defined as <60% AP use over a 3-month period. For the Control Group, less than 1 month of CGM data over a 3-month period is considered insufficient. If participants do not meet minimum use criteria in 2 successive periods, the participant will be discontinued from the study.
The investigators are targeting completion of 42 child/parent dyads combined between the Randomized substudy and the Triple Label Surveillance sub-study.
- Conditions
- Type 1 Diabetes
- Being tested
- Artificial Pancreas (AP)
- 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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Randomized substudy: Artificial Pancreas Therapy | Experimental | Participants will use a study assigned Tandem t:slim X2 with Control-IQ Technology.for two years. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized substudy: The 24-month HbA1c between AP system and Usual Care+CGM groups, performed as regression, adjusted for baseline HbA1c.
Measure of HbA1c
Measured: 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
Measured: Baseline, 12 months, 24 months
Secondary outcomes (92)
Triple Label tracer (both substudies): Change in Endogenous Glucose Production (EGP)
Change in EGP over baseline, 12 and 24 months
Measured: 24 months
Triple Label tracer (both substudies): Change in Rate of Glucose Appearance (Ra)
Change in Ra over baseline, 12 and 24 months
Measured: 24 months
Triple Label tracer (both substudies): Change in Rate of Glucose Disappearance (Rd)
Change in Rd over baseline, 12 and 24 months
Measured: 24 months
Randomized Substudy: Comparison of Glycemic Control (below also) - Time in range, overall
Time in range 70-180 mg/dL: overall
Measured: 2 years
Glycemic Control - Time in range, months 0-6
Time in range 70-180 mg/dL: months 0-6
Measured: 6 months
Glycemic Control - Time in range, months 6-12
Time in range 70-180 mg/dL: months 6-12
Measured: months 6-12
Glycemic Control - Time in range, months 12-18
Time in range 70-180 mg/dL: months 12-18
Measured: months 12-18
Glycemic Control - Insulin doses, TDI overall
Overall total daily insulin
Measured: 24 months
Glycemic Control - Time in range, months 18-24
Time in range 70-180 mg/dL: months 18-24
Measured: months 18-24
Glycemic Control - Insulin doses, TDI 0-6 months
Total daily insulin, months 0-6
Measured: 6 months
Glycemic Control - Insulin doses, TDI 6-12 months
Total daily insulin, months 6-12
Measured: months 18-24
Glycemic Control - Insulin doses, TDI 12-18 months
Total daily insulin, months 12-18
Measured: months 12-18
Glycemic Control - Insulin doses, TDI 18-24 months
Total daily insulin, months 18-24
Measured: months 18-24
Glycemic Control - Insulin doses, basal insulin total
Overall total basal insulin
Measured: 24 months
Glycemic Control - Insulin doses, basal insulin 0-6 months
Total basal insulin, months 0-6
Measured: 6 months
Glycemic Control - Insulin doses, basal insulin 6-12 months
Total basal insulin, months 6-12
Measured: months 6-12
Glycemic Control - Insulin doses, basal insulin 12-18 months
Total basal insulin, months 12-18
Measured: months 12-18
Glycemic Control - Insulin doses, basal insulin 18-24 months
Total basal insulin, months 18-24
Measured: months 18-24
Glycemic Control - Insulin doses, insulin:carb ratio overall
Overall insulin:carb ratio
Measured: 24 months
Glycemic Control - Insulin doses, insulin:carb ratio 0-6 months
Insulin:carb ratio, months 0-6
Measured: 6 months
Glycemic Control - Insulin doses, insulin:carb ratio 6-12 months
Insulin:carb ratio, months 6-12
Measured: months 6-12
Glycemic Control - Insulin doses, insulin:carb ratio 12-18 months
Insulin:carb ratio, months 12-18
Measured: months 12-18
Glycemic Control - Insulin doses, insulin:carb ratio 18-24 months
Insulin:carb ratio, months 18-24
Measured: months 18-24
Glycemic Control - Insulin doses, insulin sensitivity factor overall
Overall insulin sensitivity factor
Measured: 24 months
Glycemic Control - Insulin doses, insulin sensitivity factor 0-6 months
Insulin sensitivity factor months 0-6
Measured: 6 months
Glycemic Control - Insulin doses, insulin sensitivity factor 6-12 months
Insulin sensitivity factor months 6-12
Measured: months 6-12
Glycemic Control - Insulin doses, insulin sensitivity factor 12-18 months
Insulin sensitivity factor months 12-18
Measured: months 12-18
Glycemic Control - Insulin doses, insulin sensitivity factor 18-24 months
Insulin sensitivity factor months 18-24
Measured: months 18-24
Glycemic Control - Differences in CGM readings over prior month, Time 70-180 mg/dL
Time 70-180 mg/dL
Measured: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time <70 mg/dL
Time <70 mg/dL
Measured: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time >180 mg/dL
Time >180 mg/dL
Measured: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time >250 mg/dL
Time >250 mg/dL
Measured: 24 months
Glycemic Control - Differences in CGM readings over prior month, Number of hypoglycemia events
Number of hypoglycemia events/24 hours of CGM data available
Measured: 24 months
Glycemic Control - Differences in CGM readings over prior month, Total daily insulin injected
Total daily insulin injected (pump users only in Usual Care+CGM group)
Measured: 24 months
Triple Label Tracer, Difference in overall insulin sensitivity (SI) at 24 months
Difference in overall insulin sensitivity (SI) at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in overall insulin sensitivity (SI) at 12 months
Difference in overall insulin sensitivity (SI) at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Randomized substudy: Triple Label Tracer, Change in insulin sensitivity (SI) at 24 months
Change in insulin sensitivity (SI) at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Randomized substudy: Triple Label Tracer, Change in insulin sensitivity (SI) at 12 months
Change in insulin sensitivity (SI) at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Difference in overall Hepatic SI at 24 months
Difference in overall Hepatic SI at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in overall Hepatic SI at 12 months
Difference in overall Hepatic SI at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Change in overall Hepatic SI at 24 months
Change in overall Hepatic SI at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Change in overall Hepatic SI at 12 months
Change in overall Hepatic SI at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Difference in Peripheral SI at 24 months
Difference in Peripheral SI at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in Peripheral SI at 12 months
Difference in Peripheral SI at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Change in Peripheral SI at 24 months
Change in Peripheral SI at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Change in Peripheral SI at 12 months
Change in Peripheral SI at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Difference in Endogenous glucose uptake at 24 months
Difference in Endogenous glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in Endogenous glucose uptake at 12 months
Difference in Endogenous glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Change in Endogenous glucose uptake at 24 months
Change in Endogenous glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Change in Endogenous glucose uptake at 12 months
Change in Endogenous glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Difference in Glucose uptake at 24 months
Difference in Glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in Glucose uptake at 12 months
Difference in Glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Change in Glucose uptake at 24 months
Change in Glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Change in Glucose uptake at 12 months
Change in Glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Difference in Meal glucose uptake at 24 months
Difference in Meal glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Difference in Meal glucose uptake at 12 months
Difference in Meal glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Triple Label Tracer, Change in Meal glucose uptake at 24 months
Change in Meal glucose uptake at 24 months, AP system vs. Usual Care+CGM
Measured: 2 years
Triple Label Tracer, Change in Meal glucose uptake at 12 months
Change in Meal glucose uptake at 12 months, AP system vs. Usual Care+CGM
Measured: 1 year
Division of diabetes management responsibilities, child, difference in score at 24 months (adjusted for baseline)
Diabetes Family Responsibility Questionnaire (17 items, possible score 17-51, higher is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Division of diabetes management responsibilities, child, difference in score at 12 months (adjusted for baseline)
Diabetes Family Responsibility Questionnaire (17 items, possible score 17-51, higher is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Division of diabetes management responsibilities, parent, difference in score at 24 months (adjusted for baseline)
Diabetes Family Responsibility Questionnaire (17 items, possible score 17-51, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Division of diabetes management responsibilities, parent, difference in score at 12 months (adjusted for baseline)
Diabetes Family Responsibility Questionnaire (17 items, possible score 17-51, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Family conflict, child, difference in score at 24 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Family conflict, child, difference in score at 12 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Family conflict, parent, difference in score at 24 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Family conflict, parent, difference in score at 12 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Peer influence, child, difference in score at 24 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Peer influence, child, difference in score at 12 months (adjusted for baseline)
Diabetes Family Conflict Scale (19 items, possible score 19-57, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Diabetes distress, child, difference in score at 24 months (adjusted for baseline)
Problem Areas in Diabetes, child version (26 items, possible score 26-156, lower is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Diabetes distress, child, difference in score at 12 months (adjusted for baseline)
Problem Areas in Diabetes, child version (26 items, possible score 26-156, lower is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Diabetes distress, parent, difference in score at 24 months (adjusted for baseline)
Problem Areas in Diabetes, parent version (18 items, possible score 18-54, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Diabetes distress, parent, difference in score at 12 months (adjusted for baseline)
Problem Areas in Diabetes, parent version (18 items, possible score 18-54, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Fear of hypoglycemia, child, difference in score at 24 months (adjusted for baseline)
Hypoglycemia Fear Survey (25 items, possible score 0-100, lower is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Fear of hypoglycemia, child, difference in score at 12 months (adjusted for baseline)
Hypoglycemia Fear Survey (25 items, possible score 0-100, lower is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Fear of hypoglycemia, parent, difference in score at 24 months (adjusted for baseline)
Hypoglycemia Fear Survey (25 items, possible score 0-100, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Fear of hypoglycemia, parent, difference in score at 12 months (adjusted for baseline)
Hypoglycemia Fear Survey (25 items, possible score 0-100, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Depression, child, difference in score at 24 months (adjusted for baseline)
Child Depression Inventory-II short form (12 items, possible score 0-20, lower is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Depression, child, difference in score at 12 months (adjusted for baseline)
Child Depression Inventory-II short form (12 items, possible score 0-20, lower is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Depression in child, assessed by parent, difference in score at 24 months (adjusted for baseline)
Child Depression Inventory-II parent (17 items, possible score 0-36, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Depression in child, assessed by parent, difference in score at 12 months (adjusted for baseline)
Child Depression Inventory-II parent (17 items, possible score 0-36, lower is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Technology acceptance, child, difference in score at 24 months (adjusted for baseline)
INsulin delivery Systems, Perceptions, Ideas, Reflections and Expectations, child version (17 items, possible score 0-100, higher is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Technology acceptance, child, difference in score at 12 months (adjusted for baseline)
INsulin delivery Systems, Perceptions, Ideas, Reflections and Expectations, child version (17 items, possible score 0-100, higher is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Technology acceptance, parent, difference in score at 24 months (adjusted for baseline)
INsulin delivery Systems, Perceptions, Ideas, Reflections and Expectations, parent version (21 items, possible score 0-100, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Technology acceptance, parent, difference in score at 12 months (adjusted for baseline)
INsulin delivery Systems, Perceptions, Ideas, Reflections and Expectations, parent version (21 items, possible score 0-100, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Health-related quality of life, child, difference in score at 24 months (adjusted for baseline)
T1D and Life, youth version (23 items, possible score 0-2500, higher is better), child, AP system vs. Usual Care+CGM
Measured: 24 months
Health-related quality of life, child, difference in score at 12 months (adjusted for baseline)
T1D and Life, youth version (23 items, possible score 0-2500, higher is better), child, AP system vs. Usual Care+CGM
Measured: 12 months
Health-related quality of life, parent, difference in score at 24 months (adjusted for baseline)
T1D and Life, parent version (30 items, possible score 0-2500, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 24 months
Health-related quality of life, parent, difference in score at 12 months (adjusted for baseline)
T1D and Life, parent version (30 items, possible score 0-2500, higher is better), parent, AP system vs. Usual Care+CGM
Measured: 12 months
Both substudies: Change in HbA1c
Change in HbA1c over baseline, 12 and 24 months
Measured: 24 months
Both substudies: Change in percent time-in-range 70-180 mg/dL (TIR)
Change in TIR over baseline, 12 and 24 months
Measured: 24 months
Both substudies: Change in percent time >180 mg/dL
Change in percent time >180 mg/dL over baseline, 12 and 24 months
Measured: 24 months
Both substudies: Change in percent time <70 mg/dL
Change in percent time <70 mg/dL over baseline, 12 and 24 months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start19 Nov 2020
- Primary completion23 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc., Tandem Diabetes Care, Inc.
- Responsible party
- Principal investigator, Mark D. DeBoer, MD, MSc., MCR, University of Virginia
- Investigators
- Mark D. DeBoer, MD, MSc, MCR, Principal investigator, UVA Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510506
- Sponsor's protocol ID
- 190088
- Other IDs
- 1R01DK124886-01
- Acronym
- AP APPLE
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Pending
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Pancreas - Adolescent Physiology & Psychology Longitudinal Evaluation
- ClinicalTrials.gov ID
- NCT04510506
- Acronym / sponsor ID
- AP APPLE / 190088
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc., Tandem Diabetes Care, Inc.
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will recruit adolescents with type 1 diabetes age 11-<13 years and one parent to participate in this 24-month study. While this is admittedly a long enrollment time, study commitments following enrollment will be limited to three in-person or video visits at yearly intervals and one virtual or in-person device training session to improve adherence. Participants must be pubertal, as puberty appears to contribute significantly to the insulin resistance that is likely related to worsened blood glucose control. Pubertal assessments will occur at yearly intervals.
The first of the two arms/substudies ("Randomized" substudy) is a longitudinal randomized controlled trial for which participants will be randomized to either continue their current diabetes therapy (with the addition of use of a Dexcom CGM, forming the "Usual Care+CGM" Control Group; this includes both adolescents using non-automated insulin delivery (AID) insulin pumps or multiple daily injections [MDI]). The Experimental Group will use an AP system (Tandem's Control-IQ system) during the two-year duration of the study. The primary outcome of the Randomized substudy will be HbA1c between intervention groups at the 24-month visit.
The second arm/substudy ("Triple Label Surveillance" substudy) is an observational study. Both arms/substudies perform a "Triple Label" mixed meal study assessing glucose flux and insulin resistance that requires visits to the Clinical Research Unit. All participants will undergo a Triple-Labeled Glucose Assessment at months 0, 12 and 24. This assessment evaluates the degree of insulin resistance including in the hepatic and peripheral compartments. During Visit 2, all participants (for both the Triple Label sub-study and the Glycemia-Only sub-study) will complete multiple questionnaires assessing aspects of adolescent psychology and sociology. HbA1c will also be collected using a local lab. The primary outcome of the study overall (combined Triple Label Surveillance and Randomized substudies) is the change in insulin resistance between baseline and the 24-month visit.
CGM glucose data will be collected continuously via remote connection during the entire study. At months 6 and 18, participants will be contacted to obtain insulin management information and will have HbA1c measures assessed at a local clinic or laboratory. Additional scheduled phone calls will occur in the month before the in-person study visits to request HbA1c and confirm body composition/Triple-Labeled Glucose Assessment scheduling and discuss use of CGM and activity tracker. Participants will be contacted in the event of insufficient CGM or AP system use. For the Randomized substudy, in the Eperimental Group, insufficient use is defined as <60% AP use over a 3-month period. For the Control Group, less than 1 month of CGM data over a 3-month period is considered insufficient. If participants do not meet minimum use criteria in 2 successive periods, the participant will be discontinued from the study.
The investigators are targeting completion of 42 child/parent dyads combined between the Randomized substudy and the Triple Label Surveillance sub-study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Randomized substudy: Artificial Pancreas Therapy | Experimental | Device: Artificial Pancreas (AP)Participants will use a study assigned Tandem t:slim X2 with Control-IQ Technology.for two years. |
| 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) |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Pancreas (AP)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. | Device | Randomized substudy: Artificial Pancreas Therapy |
Primary outcome
Randomized substudy: The 24-month HbA1c between AP system and Usual Care+CGM groups, performed as regression, adjusted for baseline HbA1c.
Time frame: 2 years
Measure of HbA1c
Combined Triple Label Surveillance and Randomized substudies: Change in insulin sensitivity (Si) over time
Time frame: Baseline, 12 months, 24 months
Changes in Si (from triple-label, mixed-meal test) over time between baseline and 24 months
92 secondary outcomes
Triple Label tracer (both substudies): Change in Endogenous Glucose Production (EGP)
Time frame: 24 months
Triple Label tracer (both substudies): Change in Rate of Glucose Appearance (Ra)
Time frame: 24 months
Triple Label tracer (both substudies): Change in Rate of Glucose Disappearance (Rd)
Time frame: 24 months
Randomized Substudy: Comparison of Glycemic Control (below also) - Time in range, overall
Time frame: 2 years
Glycemic Control - Time in range, months 0-6
Time frame: 6 months
Glycemic Control - Time in range, months 6-12
Time frame: months 6-12
Glycemic Control - Time in range, months 12-18
Time frame: months 12-18
Glycemic Control - Insulin doses, TDI overall
Time frame: 24 months
Glycemic Control - Time in range, months 18-24
Time frame: months 18-24
Glycemic Control - Insulin doses, TDI 0-6 months
Time frame: 6 months
Glycemic Control - Insulin doses, TDI 6-12 months
Time frame: months 18-24
Glycemic Control - Insulin doses, TDI 12-18 months
Time frame: months 12-18
Glycemic Control - Insulin doses, TDI 18-24 months
Time frame: months 18-24
Glycemic Control - Insulin doses, basal insulin total
Time frame: 24 months
Glycemic Control - Insulin doses, basal insulin 0-6 months
Time frame: 6 months
Glycemic Control - Insulin doses, basal insulin 6-12 months
Time frame: months 6-12
Glycemic Control - Insulin doses, basal insulin 12-18 months
Time frame: months 12-18
Glycemic Control - Insulin doses, basal insulin 18-24 months
Time frame: months 18-24
Glycemic Control - Insulin doses, insulin:carb ratio overall
Time frame: 24 months
Glycemic Control - Insulin doses, insulin:carb ratio 0-6 months
Time frame: 6 months
Glycemic Control - Insulin doses, insulin:carb ratio 6-12 months
Time frame: months 6-12
Glycemic Control - Insulin doses, insulin:carb ratio 12-18 months
Time frame: months 12-18
Glycemic Control - Insulin doses, insulin:carb ratio 18-24 months
Time frame: months 18-24
Glycemic Control - Insulin doses, insulin sensitivity factor overall
Time frame: 24 months
Glycemic Control - Insulin doses, insulin sensitivity factor 0-6 months
Time frame: 6 months
Glycemic Control - Insulin doses, insulin sensitivity factor 6-12 months
Time frame: months 6-12
Glycemic Control - Insulin doses, insulin sensitivity factor 12-18 months
Time frame: months 12-18
Glycemic Control - Insulin doses, insulin sensitivity factor 18-24 months
Time frame: months 18-24
Glycemic Control - Differences in CGM readings over prior month, Time 70-180 mg/dL
Time frame: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time <70 mg/dL
Time frame: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time >180 mg/dL
Time frame: 24 months
Glycemic Control - Differences in CGM readings over prior month, Time >250 mg/dL
Time frame: 24 months
Glycemic Control - Differences in CGM readings over prior month, Number of hypoglycemia events
Time frame: 24 months
Glycemic Control - Differences in CGM readings over prior month, Total daily insulin injected
Time frame: 24 months
Triple Label Tracer, Difference in overall insulin sensitivity (SI) at 24 months
Time frame: 2 years
Triple Label Tracer, Difference in overall insulin sensitivity (SI) at 12 months
Time frame: 1 year
Randomized substudy: Triple Label Tracer, Change in insulin sensitivity (SI) at 24 months
Time frame: 2 years
Randomized substudy: Triple Label Tracer, Change in insulin sensitivity (SI) at 12 months
Time frame: 1 year
Triple Label Tracer, Difference in overall Hepatic SI at 24 months
Time frame: 2 years
Triple Label Tracer, Difference in overall Hepatic SI at 12 months
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Yes. Pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D. DeBoer, MD, MSc, MCR principal investigator
UVA Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Pancreas (AP) in people with Type 1 Diabetes, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Randomized substudy: The 24-month HbA1c between AP system and Usual Care+CGM groups, performed as regression, adjusted for baseline HbA1c. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.