Feasibility of Outpatient Closed Loop Control With the iLet Bionic Pancreas in Cystic Fibrosis Related Diabetes

NCT03258853 | Completed Results DMC FDA Device

• 1 other identifier: 2020P003452
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related diabetes.

Conditions

Cystic Fibrosis-related Diabetes

Keywords

cystic fibrosis; insulin; glucagon; continuous glucose monitor; bionic pancreas

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14

  Percentage of time spent with CGM glucose values between 70 and 180 mg/dl

  Days 3-14

Secondary Outcomes (12)

• Percentage of Time Spent With CGM Glucose: < 54 mg/dl

  Days 3-14

• Mean CGM Glucose

  Days 3-14

• Percentage of Time Spent With CGM Glucose < 70 mg/dl

  Days 3-14

• Percentage of Time Spent With CGM Glucose >180 mg/dL

  Days 3-14

• Percentage of Time Spent With CGM Glucose > 250mg/dL

  Days 3-14

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual Care diabetes management: Patients will manage their diabetes using standard of care for diabetes as per their typical regimen including use of an insulin pump or injectable insulin. Usual care arm for 14 days. Patients will wear a continuous glucose monitor (CGM) during this arm

Other: Usual Care

Insulin only bionic pancreas

EXPERIMENTAL

Insulin Only Bionic Pancreas diabetes management, a wearable bionic pancreas system that automatically delivers insulin using a continuous glucose monitoring (CGM) device, for 14 days.

Device: Bionic Pancreas

Interventions

Bionic Pancreas DEVICE

Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.

Insulin only bionic pancreas

Usual Care OTHER

Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.

Usual Care

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 10 years and have had a diagnosis of cystic fibrosis related diabetes (CFRD) managed using either an insulin pump or multiple daily injections (MDI).
• Mean continuous glucose monitoring (CGM) glucose \>/=125 mg/dl as determined by the participant's personal CGM 30-day download if CGM is used as part of their usual care. If the participant does not use CGM, hemoglobin A1c \>/= 6% within the last 6-months from available medical records will be required.
• Minimum insulin requirement of \>/=0.1u/kg/day. To ensure that participants with a wide range of insulin requirements are included, participants whose insulin requirement is \<0.3u/kg/day will be limited to approximately 1/3 of the enrolled \>/=18 year old adult cohort.
• Willing to wear iLet infusion sets and one Dexcom CGM sensor and change sets at least every other day in the iLet arm
• Assent will be obtained for patients \<18 of age

You may not qualify if:

• Diabetes from etiologies other than CFRD
• 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)
• Current participation in another clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
• Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the next 3-months, or sexually active without use of contraception
• o Participants must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
• History of hypoglycemic seizures (grand-mal) or coma in the last year
• Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.
• Unable to avoid hydroxyurea for duration of study (interferes with accuracy of Dexcom G6 CGM)
• Unable to avoid taking higher than the maximum dose of acetaminophen from all sources for the duration of the study (interferes with accuracy of Dexcom G6 CGM)
• Adult: 1 g every 6 hours, up to 4 g every 24 hours
• Pediatric: 75 mg/kg/day in up to 5 doses, not to exceed 4000 mg/day
• Have started or stopped a cystic fibrosis transmembrane conductance regulator (CFTR) modulator in the past 4 weeks.
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study
• History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Beta Bionics, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Insulin Resistance

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Melissa Putman
• Organization: Massachusetts General Hospital

msputman@mgh.harvard.edu

617-726-1847

Study Officials

• Melissa S Putman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: August 26, 2021
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-07

Data Sharing

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

Locations

US (1)