Back to resultsCGM Use in Islet Transplant Recipients
Primary Purpose
Islet Transplantation, Type1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor (CGM)
Sponsored by
About this trial
This is an interventional other trial for Islet Transplantation focused on measuring Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)
Eligibility Criteria
Inclusion Criteria:
- Type 1 Diabetes Mellitus
- Recipient of Islet Transplantation
- Age 18 or older
- Females, not currently know to be pregnant
- Demonstration of proper mental status and cognition for the study
- Understanding and willingness to follow the protocol and informed consent form
- Access to the internet and willingness to upload data during the study, including use of personal laptop
Exclusion Criteria:
- Pregnancy and intent to become pregnant during trial
- Use of acetaminophen (such as Tylenol)
- Current enrollment in another intervention clinical trial that affects glucose variability
Sites / Locations
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous Glucose Monitor (CGM)
Arm Description
Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.
Outcomes
Primary Outcome Measures
Percentage Time in Range 70-180 mg/dL by CGM
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
Secondary Outcome Measures
Percentage Time in Range <70 mg/dL by CGM
Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL
Full Information
NCT ID
NCT03427931
First Posted
December 29, 2017
Last Updated
July 23, 2020
Sponsor
University of Virginia
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03427931
Brief Title
CGM Use in Islet Transplant Recipients
Official Title
Continuous Glucose Monitoring in Islet Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
DexCom, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Detailed Description
Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Islet Transplantation, Type1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Islet Transplantation, Continuous Glucose Monitor (CGM)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Glucose Monitor (CGM)
Arm Type
Experimental
Arm Description
Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months.
Intervention Type
Other
Intervention Name(s)
Continuous Glucose Monitor (CGM)
Intervention Description
Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Primary Outcome Measure Information:
Title
Percentage Time in Range 70-180 mg/dL by CGM
Description
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
Time Frame
28-90 days
Secondary Outcome Measure Information:
Title
Percentage Time in Range <70 mg/dL by CGM
Description
Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL
Time Frame
28-90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 Diabetes Mellitus
Recipient of Islet Transplantation
Age 18 or older
Females, not currently know to be pregnant
Demonstration of proper mental status and cognition for the study
Understanding and willingness to follow the protocol and informed consent form
Access to the internet and willingness to upload data during the study, including use of personal laptop
Exclusion Criteria:
Pregnancy and intent to become pregnant during trial
Use of acetaminophen (such as Tylenol)
Current enrollment in another intervention clinical trial that affects glucose variability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue A Brown, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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CGM Use in Islet Transplant Recipients
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