Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth
Condition: 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
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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).
    

Intervention name(s): Bionic Pancreas; Telehealth; Usual Care
Intervention type(s): Device; Other; Other
Intervention description(s): 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.; Study participation will be managed via telehealth visits.; 14 days of the participant's usual care of their type 1 diabetes
Other intervention name(s): BP; TH; UC
Intervention MeSH terms: Pancrelipase
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Random-order cross over trial in a home-use setting with two 14-day study arms
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bionic pancreas; closed loop; insulin; Pancreas, Artificial; automated insulin delivery system; t1d; t1dm