Who is eligible for clinical trial NCT04333823?

Participants must meet the protocol's inclusion criteria for Diabetes Mellitus, Type 1. The stated age range is 12 Years to 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04333823 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2023-11-20

Adolescent Type 1 Diabetes Treatment With SGLT2i for hyperglycEMia & hyPerfilTration Trial (NCT04333823)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: The Hospital for Sick Children

🩺 Plain-English Summary (8th-Grade Level)

The ATTEMPT (Adolescent Type 1 diabetes Treatment with SGLT2i for hyperglycEMia \& hyPerfilTration Trial) is a multi-center, double-blinded, randomized, placebo-controlled trial to evaluate the effect of treatment with Dapagliflozin when compared to placebo, in combination with adjustable insulin, on measured GFR in adolescents with T1D 12 to \<19 years of age over a 16-week treatment period.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (17 items).

Location: Children's Hospital Colorado Anschutz Medical Campus — Aurora, Colorado

Age range: 12 Years to 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Capacity to consent; participants or their parents/legal guardians or responsible representatives must be willing and able to give signed informed consent. Participants without capacity must provide assent where applicable.
Diagnosis of Type 1 Diabetes, defined by American Diabetes Association Criteria, for at least 12 months.
Sex: Male and Female.
Age: 12 years to \<19 years.
HbA1c: 7.0-10 % at time of screening. Participants with a lower (6.5 to \<7.0%) or a higher HbA1c (\>10.0 to 11.0%) may be considered, based upon investigator discretion, if patient is adherent with study safety criteria, including a good understanding of diabetes management, regular and consistent blood glucose monitoring, appropriate ketone testing and DKA symptom recognition, appropriate adjustment of insulin doses for meals and activity as well as illness.
On Insulin Therapy: Daily injections, to include TID (three times a day), multiple daily dose insulin injection (MDI, \> 3 injections daily) or Pump (CSII).
A minimum total daily dose (TDD) of insulin ≥0.6 Units/kilogram/day.
Females of child bearing potential must be willing to use medically acceptable contraception for the duration of the study and at least one week plus 30 days (one menstrual cycle) post last dose of study drug.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Pregnancy (positive serum or urine pregnancy test) or breastfeeding.
Allergies to any member of SGLT2i class of medications.
Type 2 diabetes, Maturity onset Diabetes of Young (MODY) as defined by American Diabetes Association Criteria or pancreatic disorders with resultant impaired pancreatic function.
Body Mass Index \> 99.9th percentile by age and sex.
Presence of severe hypoglycemic event requiring assistance or glucagon rescue medication within 30 days of screening visit.
Presence of documented Diabetic Ketoacidosis (DKA) within 90 days of screening visit.
Current and/or anticipated adoption of a carbohydrate-restrictive diet
Current eating disorder or weight loss \>10% of body weight within 90 days of screening visit.
Current and or/anticipated systemic corticosteroid therapy for greater than 5 days (not including inhaled, topical, eye or ear drops containing corticosteroids).
Current or history of alcohol, drug or substance abuse.
Participation in another drug intervention study within the past 30 days.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

Children's Hospital Colorado Anschutz Medical Campus — Aurora, Colorado
London Health Sciences Centre Children's Hospital — London, Ontario
The Hospital for Sick Children — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗