NCT03353415

Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The CGM devices used in this study are approved by the Food and Drug Administration (FDA) for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if these CGM devices are able to benefit people who have had gastric surgery and experience low blood sugar episodes, which can be asymptomatic and lead to complications, impairing safety. This study involves wearing a CGM sensor/transmitter during first a masked phase (unable to see CGM sensor glucose levels), followed by an unmasked phase (able to see and respond to sensor glucose levels and alarms). Participants are asked to regularly record fingerstick (capillary) blood sugar values and any symptoms experienced, as well as a record of treatments for symptoms and glucose levels. Participants attend three to five study visits: 5 visits for participants who wore the Dexcom G4, and 3 visits for participants who wore the Dexcom G6. The Dexcom G4 became unavailable during the course of the study when the G6 was introduced. (The Dexcom G4 had a 7 day wear period versus a 10 day wear period for the G6. As the G6 has a longer wear period, the frequency of the study visits was able to be decreased). This study also involves the use of a fitness tracker, which will be worn for the duration of the study and returned at the end of the study. Participants wearing the Dexcom G4 device were able to keep the Dexcom G4 CGM receiver and transmitter (this was not possible with the Dexcom G6 system).

Conditions

• Hypoglycemia, Reactive
• Hypoglycemia

Interventions

Type	Name	Description
DEVICE	Dexcom CGM masked	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).
DEVICE	Dexcom CGM unmasked	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).

Timeline

• Start date: 2019-02-07
• Primary completion: 2021-11-11
• Completion: 2023-04-12
• First posted: 2017-11-27
• Last updated: 2023-08-28
• Results posted: 2023-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study