Recruiting

Closed Loop

Sponsor:

Boston Medical Center

Code:

NCT06236607

Conditions

Diabetes Mellitus, Type 1

Diabetes Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Device specific training

Study clinician/educator visit

Study Details

Brief summary:

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. Use of this technology by individuals with T1D from underserved communities remains very low.

The investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.

Participants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg/dL and % time < 70 mg/dL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).

Conditions

Diabetes Mellitus, Type 1

Diabetes Complications

Study ID

NCT06236607

Start date

Feb 27, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Multiple daily injections

Participants randomized into this arm will use multiple daily injections of insulin.

experimental: BetaBionics iLet HCL system

Participants randomized into this arm will use the BetaBionics iLet HCL system.

experimental: Insulet OP 5 HCL system

Participants randomized into this arm will use the Insulet OP 5 HCL system.

experimental: Tandem Control IQ HCL system

Participants randomized into this arm will use the Tandem Control IQ HCL system.

Interventions

Device specific training

Device-specific training materials from the manufactures will be used. The study clinician/pump trainer will use a pump readiness check-list to evaluate the training needs.

Study clinician/educator visit

Participants will receive insulin dose and other diabetes management guidance.

Primary outcome measure

  • Glucose time-in-range (TIR) of 70-180 mg/dL [ Time Frame: baseline, 39 weeks ]

Central Contacts and Locations

Central contacts

Howard Wolpert, MD

617-285-9096howard.wolpert@bmc.org

Astrid Atakov Castillo, BA

617-638-5906Astrid.AtakovCastillo@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Howard Wolpert, MD

617-285-9096howard.wolpert@bmc.org

Montefiore Einstein Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Nathalie Zavala, MPH

718-839-7322nathalie.zavala@einsteinmed.edu

More Information

Sponsor

Boston Medical Center

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Hybrid closed loop (HCL)
  • HCL pump therapy
  • Multiple daily injections (MDI)
  • Continuous glucose monitoring (CGM)
  • Glucose time-in-range (TIR)
  • Glucose management indicator (GMI)
  • Diabetic ketoacidosis
  • Patient reported outcomes (PRO)
  • Ecological momentary assessment (EMA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-04-01.