CGM Use in Islet Transplant Recipients

NCT ID: NCT03427931

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-07-11

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.

Conditions

Islet Transplantation; Type1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous Glucose Monitor (CGM)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sue Brown

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sue A Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20294

Identifier Type: -

Identifier Source: org_study_id