CGM Use in Islet Transplant Recipients

Type1 Diabetes Mellitus Clinical Trial

Official title:

Continuous Glucose Monitoring in Islet Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427931
• Other study ID #: 20294
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: July 11, 2019

Study information

• Verified date: July 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Islet Transplantation
• Type1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc., University of Virginia Strategic Investment Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28-90 days
Secondary	Percentage Time in Range <70 mg/dL by CGM	Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL	28-90 days