Taking people in United StatesNo phase

Testing Hybrid Closed Loop Insulin Pumps in Adults With Type 1 Diabetes

Tests automated insulin pump systems against standard injections in adults with type 1 diabetes.

Key facts

Who runs it: Boston Medical Center
Where: Boston and The Bronx, United StatesSee the 2 sites
Trial code: NCT06236607
Registry title: Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes
Status: Recruiting
People taking part: 140 people, planned
Started: 27 Feb 2025
Expected to end: Sept 2028
Type of study: Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Device specific training
Study clinician/educator visit
Record updated: 1 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes who use insulin injections and have an A1c of 7.0% (53 mmol/mol) or higher. It tests hybrid closed loop pump therapy.

Age: 18 to 75 years
Sex: All sexes can join.
Disease stage: Type 1 diabetes for at least 12 months, on multiple daily injections for at least 6 months. A1c of 7.0% (53 mmol/mol) or higher, with no upper limit.
Earlier treatment: Must have used multiple daily insulin injections for at least 6 months. Must not currently use an insulin pump or closed loop system.
Biomarker or test result: A1c of 7.0% (53 mmol/mol) or higher at screening. Total daily insulin dose of at least 10 units/day.

Main reasons for not taking part

Currently using an insulin pump or closed loop pump system
Pregnant or planning to become pregnant
Current dialysis, or most recent eGFR under 30 ml/min
Active cancer treatment
Current use of SGLT-2 inhibitors or sulfonylureas

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

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

Who cannot take part

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
Active cancer treatment
Extreme visual or hearing impairment that would impair ability to use CGM and pump
Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate
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)
Current use of insulin pump or closed loop insulin pump system
Unable to provide informed consent
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)
Cognitive concerns

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in United States

Boston Medical CenterBoston, United StatesContact: Howard Wolpert, MDTaking people
Montefiore Einstein Medical CenterThe Bronx, United StatesContact: Nathalie Zavala, MPHTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 4 groups in the trial

Multiple daily injectionsExisting treatment, for comparison
Participants randomized into this arm will use multiple daily injections of insulin.
Treatment: Study clinician/educator visit
BetaBionics iLet HCL systemTreatment being tested
Participants randomized into this arm will use the BetaBionics iLet HCL system.
Treatment: Device specific training
Insulet OP 5 HCL systemTreatment being tested
Participants randomized into this arm will use the Insulet OP 5 HCL system.
Treatment: Device specific training
Tandem Control IQ HCL systemTreatment being tested
Participants randomized into this arm will use the Tandem Control IQ HCL system.
Treatment: Device specific training