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

Not Applicable

Completed

• Conditions: Diabetes, Autoimmune; Diabetes type1; Insulin-Dependent Diabetes Mellitus 1; Autoimmune Diabetes; Diabetes Mellitus, Insulin-Dependent; Diabetes Mellitus, Ketosis-Prone; Diabetes Mellitus, Sudden-Onset; Diabetes Mellitus, Type 1; Type 1 Diabetes; Diabetes Mellitus, Brittle
• Interventions: Other: Usual Care; Device: Bionic Pancreas; Other: Telehealth

• Registration Number: NCT05168657
• Lead Sponsor: University of Colorado, Denver

Brief 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).

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-23
• Study Start: 2022-03-31
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Results First Submitted: 2024-05-20
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Results First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EN-TH-BP	Telehealth	Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
PC-TH-UC	Telehealth	Random-order cross-over participants on USUAL CARE managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
EN-IP-UC	Usual Care	Random-order cross-over participants on USUAL CARE managed by ENDOCRINOLOGY with IN-PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
PC-TH-BP	Telehealth	Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
EN-IP-BP	Bionic Pancreas	Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
EN-TH-BP	Bionic Pancreas	Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
EN-TH-UC	Telehealth	Random-order cross-over participants on USUAL CARE managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
PC-IP-UC	Usual Care	Random-order cross-over participants on USUAL CARE intervention managed by PRIMARY CARE with IN-PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
PC-IP-BP	Bionic Pancreas	Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.
PC-TH-BP	Bionic Pancreas	Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days.

Primary Outcome Measures

Name	Time	Method
Percentage of Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group.	BP Arm Days 3-14	The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.

Secondary Outcome Measures

Name	Time	Method
Mean CGM Glucose on Days 3-14	BP Arm Days 3-14	Individual CGM values from days 3-14 were averaged together for each participant.
Percentage of Time With CGM Glucose <54 mg/dl on Days 3-14	BP Arm Days 3-14	Calculated from all individual CGM values from days 3-14 for each participant.
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range on Days 3-14	BP Arm Days 3-14	Calculated from all individual CGM values from days 3-14 for each participant.
Percentage of Individuals With Mean CGM Glucose <154 mg/dL (Corresponding to an Estimated HbA1c of <7.0%) on Days 3-14, by Group.	BP Arm Days 3-14	Calculated from all individual CGM values from days 3-14 for each participant.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States