NCT03258853
Completed
Not Applicable
Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes
ConditionsCystic Fibrosis-related Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis-related Diabetes
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Melissa Susan Putman
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
Time Frame: Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Secondary Outcomes
- Mean CGM Glucose(Days 3-14)
- Standard Deviation(Days 3-14)
- Coefficient of Variation(Days 3-14)
- Number of Subjects With Mean CGMG <154 mg/dl(Days 3-14)
- Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl(Days 3-14)
- Percentage of Time Spent With CGM Glucose: < 54 mg/dl(Days 3-14)
- Percentage of Time Spent With CGM Glucose < 70 mg/dl(Days 3-14)
- Number of Subjects With Percentage of Time < 54 mg/dl < 1%(Days 3-14)
- Percentage of Time Spent With CGM Glucose > 250mg/dL(Days 3-14)
- Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater(Days 3-14)
- Number of Episodes of Self-reported Symptomatic Hypoglycemia(Days 3-14)
- Percentage of Time Spent With CGM Glucose >180 mg/dL(Days 3-14)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Closed-Loop Glucagon Administration For Hypoglycemia TreatmentType 1 DiabetesNCT02181127Massachusetts General Hospital31
Completed
Not Applicable
A Multicenter Study of Outpatient Automated Blood Glucose Control With a Bihormonal Bionic PancreasDiabetes Mellitus Type 1NCT02092220Massachusetts General Hospital48
Completed
Not Applicable
Outpatient Automated Blood Glucose Control With a Bi-hormonal Bionic Endocrine PancreasType 1 DiabetesNCT01762059Massachusetts General Hospital32
Withdrawn
Not Applicable
Inpatient Closed Loop Glucose Control With the Gen 2 GlucoSTATType 1 DiabetesType 2 Diabetes Treated With InsulinNCT04227626Massachusetts General Hospital
Completed
Not Applicable
The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine PancreasType 1 DiabetesNCT02105324Massachusetts General Hospital19