CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Dexcom CGM masked +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03353415
NCT03353415N/ACompleted

Determining the Efficacy of Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery

Joslin Diabetes Center·interventional·Posted Nov 27, 2017·Updated Aug 28, 2023

In Brief

A clinical study evaluating Dexcom CGM masked and Dexcom CGM unmasked for Hypoglycemia, Reactive and Hypoglycemia. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this study is to see if the use of a continuous glucose monitor (CGM) by people who experience low blood sugars (hypoglycemia) after gastric surgery can help reduce the number and severity of low blood sugar episodes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDexCom, Inc.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 27, 2017
Enrollment StartFeb 7, 2019
Primary CompletionNov 11, 2021
Study CompletionApr 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.6 years ago

Interventions

Dexcom CGM maskeddevice

The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)). The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).

Dexcom CGM unmaskeddevice

During the second phase (2 weeks for the Dexcom G4 and 10 days for the Dexcom G6), participants are able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).