NCT03427931

CGM Use in Islet Transplant Recipients

Completed NA Results posted Last updated 7 August 2020

What this trial tests

NA trial testing Continuous Glucose Monitor (CGM) in Islet Transplantation in 7 participants. Completed in 11 July 2019.

Timeline

1 February 2018

Primary endpoint
11 July 2019

11 July 2019

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	7
Start date	1 February 2018
Primary completion	11 July 2019
Estimated completion	11 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Continuous Glucose Monitor (CGM)

Conditions studied

• Islet Transplantation — all drugs for Islet Transplantation →
• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Islet Transplantation or Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Time in Range 70-180 mg/dL by CGM Primary · 28-90 days

Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL

Group	Value	95% CI
Continuous Glucose Monitor (CGM)	77	± 12

Percentage Time in Range <70 mg/dL by CGM Secondary · 28-90 days

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

Group	Value	95% CI
Continuous Glucose Monitor (CGM)	3.6	± 3.2

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.