Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Conditions

• Diabetes Complications
• Diabetes Mellitus, Type 1

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Device specific training — DEVICE
  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 — OTHER
  Participants will receive insulin dose and other diabetes management guidance.

Study Details

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).

Key Dates

Start date

Feb 27, 2025

Status verified

Mar 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Howard Wolpert, MD
  617-285-9096
  [email protected]
• Astrid Atakov Castillo, BA
  617-638-5906
  [email protected]

Locations (2)

Find similar trials in Boston, MA

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