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Artificial Pancreas for Type 1 Diabetes (AP APPLE Trial)
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.
AP APPLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAP APPLE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 41 Patients • NCT02137382AP APPLE Trial Design
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Who is running the clinical trial?
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- I have started puberty.I am between 11 and 13 years old and have a guardian willing to join the study with me.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.You are a female of childbearing potential who is willing to use a form of contraception to prevent pregnancy while participating in the studyI have been using insulin for at least 6 months.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 diagnosed with type 1 diabetes for at least a year.I have been using insulin for at least six months.I am not pregnant or breastfeeding.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.
- Group 1: Randomized substudy: Artificial Pancreas Therapy
- Group 2: Randomized substudy: Usual Care + CGM
- Group 3: Triple Label Surveillance substudy (observational arm)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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)."
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."
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."
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."
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"
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