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

NCT05168657 | Completed Results DMC FDA Device

• 1 other identifier: 21-3272
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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).

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

Keywords

bionic pancreas; closed loop; insulin; Pancreas, Artificial; automated insulin delivery system; t1d; t1dm

Outcome Measures

Primary Outcomes (1)

• Percentage of Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group.

  The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.

  BP Arm Days 3-14

Secondary Outcomes (4)

• Mean CGM Glucose on Days 3-14

  BP Arm Days 3-14

• Percentage of Time With CGM Glucose <54 mg/dl on Days 3-14

  BP Arm Days 3-14

• Percentage of Time With CGM Glucose in the 70-180 mg/dl Range on Days 3-14

  BP Arm Days 3-14

• 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

Study Arms (8)

EN-IP-UC first, Then BP

EXPERIMENTAL

Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Other: Usual Care

EN-TH-UC first, Then BP

EXPERIMENTAL

Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Other: Usual Care

EN-IP-BP first, Then UC

EXPERIMENTAL

Random-order cross-over participants managed by ENDOCRINOLOGY with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Device: Bionic Pancreas

EN-TH-BP first, Then UC

EXPERIMENTAL

Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Device: Bionic Pancreas

PC-IP-UC first, Then BP

EXPERIMENTAL

Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Other: Usual Care

PC-TH-UC first, Then BP

EXPERIMENTAL

Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms.

Other: Usual Care

PC-IP-BP first, Then UC

EXPERIMENTAL

Random-order cross-over participants managed by PRIMARY CARE with IN PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Device: Bionic Pancreas

PC-TH-BP first, Then UC

EXPERIMENTAL

Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms.

Device: Bionic Pancreas

Interventions

Bionic Pancreas DEVICE

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.

Also known as: BP

EN-IP-BP first, Then UC; EN-TH-BP first, Then UC; PC-IP-BP first, Then UC; PC-TH-BP first, Then UC

Usual Care OTHER

14 days of the participant's usual care of their type 1 diabetes

Also known as: UC

EN-IP-UC first, Then BP; EN-TH-UC first, Then BP; PC-IP-UC first, Then BP; PC-TH-UC first, Then BP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years, BMI ≥ 18.5, have had clinical type 1 diabetes for at least one year, and have taken insulin for at least 1 year
• Prescription diabetes medication regimen stable for \> 1 month, including any adjunctive anti-diabetic medications (except for medications that will not affect the safety of the study and are not expected to affect any outcome of the study, in the judgment of the site principal investigator)
• This does not include changes to any insulin doses, including basal rates/long-acting insulin doses, carbohydrate to insulin ratios and correction factors
• Willing to wear one Dexcom CGM transmitter and sensor (sensor must be changed every 10 days), and one infusion set that must be replaced at least every 3 days.
• Endocrinology practice criterion is that diabetes is managed using sensor-augmented insulin pump therapy or artificial pancreas therapy for ≥ 3 months)
• Primary care practice criteria are that diabetes is managed by multiple daily insulin injections (insulin-pump naïve).
• TH group criterion is that participant must have hardware and internet access capable of 2-way video and audio communication

You may not qualify if:

• Unable to provide informed consent (e.g. impaired cognition or judgment)
• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)
• Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only.
• Plan to change usual diabetes regimen in the next 3 months including before and during participation in the study
• This would include changing from MDI to pump or from pump to MDI, and starting a CGM if not previously used
• This would not include changes to any insulin doses, including basal rates/long acting insulin doses, carbohydrate to insulin ratios and correction factors
• Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system (e.g. "Loop" or "Open APS")
• Unwilling to switch to lispro or aspart for the duration of the study's iLet arm (e.g. from Fiasp or Lyumjev)
• Current participation in another diabetes-related clinical trial, has a medical condition, or use of a medication that, in the judgment of the investigator, could compromise the results of this study or the safety of the participant
• History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
• Have a history of intermittently required glucocorticoid treatment (e.g., but not limited to, for the treatment of asthma, inflammatory bowel disease).
• A1c \>11.0% (most recent value up to 1 year prior acceptable; if none available or \>1 year prior, participant will be instructed to obtain A1c through their usual care provider and to make copy of result available to study team)
• History of diabetic ketoacidosis (DKA) within the past month
• Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Beta Bionics, Inc.: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Dr. Sean Oser
• Organization: University of Colorado

sean.oser@cuanschutz.edu

3037245828

Study Officials

• Sean M Oser, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Tamara K Oser, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random-order cross over trial in a home-use setting with two 14-day study arms

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 23, 2021
• Study Start: March 31, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (2)