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Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests insulin pumps that automatically adjust some insulin doses in adults with type 1 diabetes from underserved communities. It compares these pumps with a blood sugar sensor and several daily insulin shots. Over 9 months, researchers will check blood sugar control, safety, and what it is like to use these systems.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 1 diabetes for at least 12 months and used several daily insulin shots for at least 6 months.
  • Have an A1c of at least 7.0%. This test measures average blood sugar over about 3 months. There is no upper limit, but the study doctor will review your diabetes care and past serious problems.
  • Be able to understand, speak, and read English.
  • Be willing to use only lispro or aspart insulin and not start any new non-insulin diabetes medicine during the study.
  • Use at least 10 units of insulin each day.
  • The study doctor believes you can follow the study's instructions.

Who can't join

  • Currently use an insulin pump, or cannot give informed consent (agree to join after understanding the study).
  • Take hydroxyurea or have a condition that may require it.
  • Take SGLT-2 inhibitors or sulfonylureas, types of diabetes medicines. If you take a GLP-1RA, pramlintide, or metformin, your dose must have stayed the same for 3 months before joining.
  • Have a tape allergy or skin condition that prevents use of a pump or continuous glucose monitor (blood sugar sensor).
  • Are pregnant or plan to become pregnant.
  • Receive dialysis (treatment that filters blood), plan to start it during the study, or have a latest kidney filtering test result, called eGFR, below 30 ml/min. A result from the past 2 years is accepted.
  • Are receiving cancer treatment.
  • Have severe vision or hearing loss that prevents device use, concerns about thinking or memory, or a serious mental health or substance use condition that the study doctor believes limits participation.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

MA

NY