CGM Use in Islet Transplant Recipients

July 23, 2020 updated by: Sue Brown, University of Virginia

Continuous Glucose Monitoring in Islet Transplant Recipients

A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Continuous Glucose Monitor (CGM)
Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Time in Range 70-180 mg/dL by CGM
Time Frame: 28-90 days
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
28-90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Time in Range <70 mg/dL by CGM
Time Frame: 28-90 days
Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL
28-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Sue A Brown, MD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

July 11, 2019

Study Completion (Actual)

July 11, 2019

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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