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Device

Artificial Pancreas for Type 1 Diabetes (AP APPLE Trial)

N/A
Recruiting
Led By Mark D. DeBoer, MD, MSc, MCR
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least Tanner 2 pubic hair (boys), Tanner 2 breast development (girls)
Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

AP APPLE Trial Summary

This trial will compare how well two different types of diabetes treatments work in controlling the disease in pubertal adolescents over a two year period.

Who is the study for?
This trial is for pubertal adolescents aged 11 to under 13 with Type 1 Diabetes, who have been using insulin for at least six months and have an HbA1c level below 10%. Participants need internet access to upload data and must not be pregnant or planning pregnancy. They should agree to use only specified insulins if assigned to the Control-IQ group.Check my eligibility
What is being tested?
The study tests how well an Artificial Pancreas (AP) controls Type 1 Diabetes in adolescents over two years. It includes a randomized controlled trial where participants are randomly placed into groups, and an observational study without intervention changes.See study design
What are the potential side effects?
While specific side effects of the AP aren't detailed, potential issues may include skin irritation from device wear, incorrect insulin dosing leading to low or high blood sugar levels, and possible technical malfunctions of the device.

AP APPLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have started puberty.
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My daily insulin dose is between 10 and 100 units.
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I have been diagnosed with type 1 diabetes for over a year.
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I have been using insulin for at least 6 months.
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I use insulin parameters like carb ratio and correction factors for dosing.
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I am willing to switch to and only use lispro or aspart insulin if I join the Control-IQ group.
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I am not pregnant or breastfeeding.
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I have been diagnosed with type 1 diabetes for at least a year.
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I have been using insulin for at least six months.
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I am not pregnant or breastfeeding.
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I agree not to start any new diabetes medication except insulin during the trial.
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I am between 11 and 12 years old, and my parent/guardian will participate with me.

AP APPLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Randomized substudy: The 24-month HbA1c between AP system and Usual Care+CGM groups, performed as regression, adjusted for baseline HbA1c.
Secondary outcome measures
Both substudies: Change in HbA1c
Both substudies: Change in percent time <70 mg/dL
Both substudies: Change in percent time >180 mg/dL
+89 more

Side effects data

From 2014 Phase 3 trial • 41 Patients • NCT02137382
2%
Abdominal pain lower
2%
decreased appetite
2%
Constipation
2%
Diarrhea
2%
Gastric pH decreased
2%
hypoglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creon N
Creon®

AP APPLE Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Randomized substudy: Artificial Pancreas TherapyExperimental Treatment1 Intervention
Participants will use a study assigned Tandem t:slim X2 with Control-IQ Technology.for two years.
Group II: Randomized substudy: Usual Care + CGMActive Control1 Intervention
Participant will use their usual diabetes care along with a study CGM.
Group III: Triple Label Surveillance substudy (observational arm)Active Control1 Intervention
Participants will remain on own baseline diabetes management (e.g. automated insulin delivery system, non-AID pump, MDI)

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,998 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,366 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
135 Previous Clinical Trials
29,765 Total Patients Enrolled

Media Library

Artificial Pancreas (AP) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04510506 — N/A
Type 1 Diabetes Research Study Groups: Randomized substudy: Artificial Pancreas Therapy, Randomized substudy: Usual Care + CGM, Triple Label Surveillance substudy (observational arm)
Type 1 Diabetes Clinical Trial 2023: Artificial Pancreas (AP) Highlights & Side Effects. Trial Name: NCT04510506 — N/A
Artificial Pancreas (AP) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04510506 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals of this medical investigation?

"This clinical trial, which is estimated to last two years, will be monitored at three points: baseline, 12 months and 24 months. Its primary objective is assessing the difference in HbA1c between AP system and Usual Care+CGM groups as a regression adjusted for baseline levels. Secondary objectives include measuring changes in Endogenous Glucose Production (EGP), Rate of Glucose Appearance (Ra) and Rate of Glucose Disappearance (Rd)."

Answered by AI

How many individuals are taking part in this medical examination?

"Affirmative. According to the information on clinicaltrials.gov, the trial was first published on November 19th 2020 and has been making edits as recently as October 13th 2022. The study is searching for 100 individuals from a single research site."

Answered by AI

Are there any vacancies for people to enroll in this research project?

"Indeed, according to clinicaltrials.gov the study is open for recruitment and was first posted on November 19th 2020 before being refreshed on October 13th 2022. 100 patients are needed at one medical centre."

Answered by AI

Is this research project enrolling participants who are older than thirty years of age?

"According to the specified eligibility criteria, individuals aged 11-12 can partake in this clinical trial."

Answered by AI

What criteria must be met for someone to qualify for this research project?

"This clinical trial seeks one hundred individuals aged 11-12 with type 1 diabetes mellitus. Essential criteria for enrolment include: being between 11 and 13 years old, having a parent/guardian over 18 to participate alongside the child; HbA1c <10 clinically obtained within 6 weeks (unless stay-at-home orders prevent this); diagnosis of T1DM for at least 12 months; insulin use for more than half a year; females must not be pregnant or breastfeeding, males must have Tanner 2 pubic hair and girls must display Tanner 2 breast development; both pump users and MDIs should consistently dose insulin according to carb"

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
< 18
What site did they apply to?
University of Virginia Center for Diabetes Technology
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~14 spots leftby Oct 2025