CGM Use in Islet Transplant Recipients

Not Applicable

Completed

• Conditions: Type1 Diabetes Mellitus; Islet Transplantation
• Interventions: Other: Continuous Glucose Monitor (CGM)

• Registration Number: NCT03427931
• Lead Sponsor: University of Virginia

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.

Study Timeline

• Study First Submitted: 2017-12-29
• Study Start: 2018-02-01
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Primary Completion: 2019-07-11
• Study Completion: 2019-07-11
• Status Verified: 2020-07
• Results First Submitted: 2020-07-11
• Results First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Results First Posted: 2020-08-07
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitor (CGM)	Continuous Glucose Monitor (CGM)	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.

Primary Outcome Measures

Name	Time	Method
Percentage Time in Range 70-180 mg/dL by CGM	28-90 days	Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL

Secondary Outcome Measures

Name	Time	Method
Percentage Time in Range <70 mg/dL by CGM	28-90 days	Descriptive glycemic analyses based on CGM data with glucose range \<70 mg/dL

Trial Locations

Locations (1)

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States