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Device
Artificial Pancreas for Type 1 Diabetes (AP APPLE Trial)
N/A
Waitlist Available
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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 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 using insulin for at least six months.
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I agree not to start any new diabetes medication except insulin during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Both substudies: Change in HbA1c
Both substudies: Change in percent time <70 mg/dL
Both substudies: Change in percent time >180 mg/dL
+89 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
785 Previous Clinical Trials
1,316,404 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,411 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
146 Previous Clinical Trials
35,457 Total Patients Enrolled
Tandem Diabetes Care, Inc.Industry Sponsor
40 Previous Clinical Trials
5,751 Total Patients Enrolled
Mark D. DeBoer, MD, MSc, MCRPrincipal Investigator - UVA Center for Diabetes Technology
University of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have started puberty.Your blood sugar level, as measured by hemoglobin A1c, is higher than 10% in the past 6 weeks.My daily insulin dose is between 10 and 100 units.Your HbA1c level should be less than 10 and should have been checked in the last 6 weeks at a medical facility or using a home HbA1c device or an outside laboratory.I have been diagnosed with type 1 diabetes for over a year.Your blood sugar level (HbA1c) needs to be less than 10, and this can be tested at a lab, clinic, or at home.I use insulin parameters like carb ratio and correction factors for dosing.I am willing to switch to and only use lispro or aspart insulin if I join the Control-IQ group.I am not pregnant or breastfeeding.I have been using insulin for at least six months.I agree not to start any new diabetes medication except insulin during the trial.I am between 11 and 12 years old, and my parent/guardian will participate with me.
Research Study Groups:
This trial has the following groups:- Group 1: Randomized substudy: Artificial Pancreas Therapy
- Group 2: Randomized substudy: Usual Care + CGM
- Group 3: Triple Label Surveillance substudy (observational arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.