CGM Use in Islet Transplant Recipients
Continuous Glucose Monitoring in Islet Transplant Recipients
1 other identifier
interventional
7
1 country
1
Brief Summary
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2019
CompletedResults Posted
Study results publicly available
August 7, 2020
CompletedAugust 7, 2020
July 1, 2020
1.4 years
December 29, 2017
July 11, 2020
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
28-90 days
Secondary Outcomes (1)
Percentage Time in Range <70 mg/dL by CGM
28-90 days
Study Arms (1)
Continuous Glucose Monitor (CGM)
EXPERIMENTALStudy 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.
Interventions
Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- DexCom, Inc.collaborator
Study Sites (1)
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sue Brown, MD
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Sue A Brown, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 29, 2017
First Posted
February 9, 2018
Study Start
February 1, 2018
Primary Completion
July 11, 2019
Study Completion
July 11, 2019
Last Updated
August 7, 2020
Results First Posted
August 7, 2020
Record last verified: 2020-07