Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes

• 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.

Primary outcomes

• Glucose time-in-range (TIR) of 70-180 mg/dL [baseline, 39 weeks]: The glucose TIR will be measured over 2 weeks using continuous glucose monitoring (CGM).

Secondary outcomes

• Glucose time < 70 mg/dL [baseline, 39 weeks]: The glucose time <70 mg/dL will be measured over 2 weeks using continuous glucose monitoring (CGM).
• Glucose management indicator (GMI) [baseline, 39 weeks]: The GMI will be measured using continuous glucose monitoring (CGM).
• A1C [baseline, 39 weeks]: A hemoglobin A1C test is a blood test that measures a person's average blood glucose level over the previous three months.
• Body weight [baseline, 39 weeks]: Participants' body weight will be measured and recorded.
• Diabetic Ketoacidosis events [baseline, 39 weeks]: Events of diabetic ketoacidosis with be abstracted electronic and medical record review and from patient report.

Sex: All, ages: 18 Years to 75 Years

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.

• Howard Wolpert, MD, Principal investigator, Boston Medical Center

NIH grants: R01DK138309