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Tests treatment safety and results for Diabetes Mellitus, Type 1
Official title Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06236607
What this study is testing
- What it's testing
- Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
- A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management...
- Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, people who are not able to...
- Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
- Total daily dose of insulin of at least 10 units/day;
You likely can't join if
- Current use of insulin pump or closed loop insulin pump system;
- Unable to provide informed consent;
- Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
- Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to...
- Tape allergy or skin condition precluding use of pump or CGM;
- Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be...
See the full eligibility criteria
- Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;
- A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no...
- Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, people who are not able to understand written English will not be eligible);
- Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;
- Total daily dose of insulin of at least 10 units/day;
- Investigator believes that the participant will be able to successfully adhere to the study protocol.
- Current use of insulin pump or closed loop insulin pump system;
- Unable to provide informed consent;
- Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;
- Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);
- Tape allergy or skin condition precluding use of pump or CGM;
- Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);
- Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR \<30 ml/min is exclusionary (within last 2 years is acceptable);
- Active cancer treatment;
- Extreme visual or hearing impairment that would impair ability to use CGM and pump;
- Cognitive concerns;
- Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.