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Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

NCT06236607·2 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Howard Wolpert, MD
CONTACT
617-285-9096 howard.wolpert@bmc.org
Astrid Atakov Castillo, BA
CONTACT
617-638-5906 Astrid.AtakovCastillo@bmc.org

Lead

Boston Medical Center

With

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Age

18–75

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible 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, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);
Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects 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.

You may not be 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 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 record

StatusRecruiting

PhaseNot applicable

Taking part140

StartedFeb 2025

UpdatedApr 1, 2026

Conditions

Diabetes Mellitus, Type 1 Diabetes Complications

Where2

Boston Medical Center
Boston, Massachusetts, United States
Montefiore Einstein Medical Center
The Bronx, New York, United States