NCT05168657

Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth

Assessing Feasibility, Safety, and Efficacy of Deploying a Closed-loop Automated Insulin Delivery System by Community-based Primary Care Physicians and Academic Endocrinologists, in Person and Through Telehealth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH).

Detailed description

This is a study assessing the feasibility of deploying the iLet bionic pancreas system in the insulin-only configuration to pump-naïve MDI users with type 1 diabetes, in the setting of being recruited from community-based primary care practices and being trained and managed by primary care providers (PC group), and in pump- and CGM-experienced (sensor-augmented pump or hybrid closed-loop) users with type 1 diabetes recruited from, trained, and managed by an academic endocrinology practice (EN group). In both practice settings, the exclusive use of telehealth (TH) visits will be assessed, as will the use of in-person (IP) visits. We will enroll 40 adult volunteers (≥ 18 years old) with type 1 diabetes, 20 who are insulin pump naïve MDI users enrolled from community primary care practices by University of Colorado Family Medicine (PC group) and 20 who are technology-savvy sensor-augmented pump or hybrid closed-loop users enrolled by the Massachusetts General Hospital Diabetes Clinical Research Center (EN group). Ten of the participants at each center will be trained and managed throughout the trial using in-person visits (PC-IP and EN-IP groups) and the other ten from each center will be trained and managed throughout the trial exclusively via telehealth visits (PC-TH and EN-TH groups). This will result in four study cohorts overall (endocrinology in-person, endocrinology telehealth, primary care in-person, primary care telehealth). Subjects in all four groups will each participate, in random order, in one 14-day study arm under their own usual care (UC arm) and one 14-day study arm under the insulin-only configuration of the iLet bionic pancreas (iLet arm).

Conditions

• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Diabetes, Autoimmune
• Diabetes type1
• Autoimmune Diabetes
• Diabetes Mellitus, Brittle
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Insulin-Dependent, 1
• Diabetes Mellitus, Juvenile-Onset
• Diabetes Mellitus, Ketosis-Prone
• Diabetes Mellitus, Sudden-Onset
• Insulin-Dependent Diabetes Mellitus 1
• Juvenile-Onset Diabetes
• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Bionic Pancreas	14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.
OTHER	Usual Care	14 days of the participant's usual care of their type 1 diabetes

Timeline

• Start date: 2022-03-31
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2021-12-23
• Last updated: 2024-10-21
• Results posted: 2024-10-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study