CGM Use in Islet Transplant Recipients

University of Virginia7 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Islet Transplantation Type1 Diabetes Mellitus

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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

Time frame: 28-90 days

Secondary Outcomes

Percentage Time in Range <70 mg/dL by CGM

Descriptive glycemic analyses based on CGM data with glucose range \<70 mg/dL

Time frame: 28-90 days

Data from ClinicalTrials.gov

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