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

Not Applicable

Completed

• Conditions: Cystic Fibrosis-related Diabetes
• Interventions: Device: Bionic Pancreas; Other: Usual Care

• Registration Number: NCT03258853
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-23
• Study Start: 2021-08-26
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Results First Submitted: 2023-05-24
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Results First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin only bionic pancreas	Bionic Pancreas	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.
Usual Care	Usual Care	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

Primary Outcome Measures

Name	Time	Method
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14	Days 3-14	Percentage of time spent with CGM glucose values between 70 and 180 mg/dl

Secondary Outcome Measures

Name	Time	Method
Mean CGM Glucose	Days 3-14	Average CGM glucose
Standard Deviation	Days 3-14	Standard deviation of participants' mean CGM glucose
Coefficient of Variation	Days 3-14	Coefficient of variation of CGM glucose values
Number of Subjects With Mean CGMG <154 mg/dl	Days 3-14	Number of subjects who achieve a mean CGM glucose \< 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)
Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl	Days 3-14	Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl
Percentage of Time Spent With CGM Glucose: < 54 mg/dl	Days 3-14	Percentage of time spent with CGM glucose in this range
Percentage of Time Spent With CGM Glucose < 70 mg/dl	Days 3-14	Percent of time the participant spent with CGM glucose in this range
Number of Subjects With Percentage of Time < 54 mg/dl < 1%	Days 3-14	Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl
Percentage of Time Spent With CGM Glucose > 250mg/dL	Days 3-14	The percent of time the participant spent with CGM glucose in this range
Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater	Days 3-14	Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
Number of Episodes of Self-reported Symptomatic Hypoglycemia	Days 3-14	Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
Percentage of Time Spent With CGM Glucose >180 mg/dL	Days 3-14	The percent of time the participant spent with CGM glucose in this range

Trial Locations

Locations (1)

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