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OpenTrials
Completed

NCT Number: NCT03427931

CGM Use in Islet Transplant Recipients

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

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Key information

Conditions

Islet Transplantation Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type1 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor (CGM)

Other

Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.

Primary outcomes

  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 of glucose between 70-180 mg/dL

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

Continuous Glucose Monitoring in Islet Transplant Recipients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2018
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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