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CGM Use in Islet Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03427931
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborators:
University of Virginia Strategic Investment Fund
DexCom, Inc.
Information provided by (Responsible Party):
Sue Brown, University of Virginia

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

Condition or disease Intervention/treatment Phase
Islet Transplantation Type1 Diabetes Mellitus Other: Continuous Glucose Monitor (CGM) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Continuous Glucose Monitoring in Islet Transplant Recipients
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  1. 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 70-180 mg/dL


Secondary Outcome Measures :
  1. Percentage time in range <70 mg/dL by CGM [ Time Frame: 28-90 days ]
    Descriptive glycemic analyses based on CGM data



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427931


Contacts
Contact: Sue A. Brown, MD 434-982-0602 sab2f@virginia.edu
Contact: Matthew Kime, BS 434-924-5529 mak3mf@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Diabetes Technology Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sue A Brown, MD    434-982-0602    sab2f@virginia.edu   
Contact: Matthew Kime, BS    434-924-5529    mak3mf@virginia.edu   
Sub-Investigator: Jose Oberholzer, MD         
Sponsors and Collaborators
University of Virginia
University of Virginia Strategic Investment Fund
DexCom, Inc.
Investigators
Principal Investigator: Sue A Brown, MD University of Virginia

Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03427931     History of Changes
Other Study ID Numbers: 20294
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sue Brown, University of Virginia:
Type 1 Diabetes Mellitus
Islet Transplantation
Continuous Glucose Monitor (CGM)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases