Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypoglycemia
- Hypoglycemia, Reactive
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Specifically, we will analyze glycemic patterns during 2 weeks of unmasked CGM wear, in comparison to the baseline 2 weeks of masked CGM wear. Please note that we have chosen to have a consistent masked monitoring first, as providing unmasked data to participants first could alter their dietary or other patterns and reduce ability of the study to independently assess efficacy of the CGM intervention.Masking: None (Open Label)Masking Description: The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Participants themselves will not be masked to study design. The only masking will be of the device itself during the first 2 weeks of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
The continuous glucose monitor (CGM) that will be used in this study is already approved by the FDA for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if this CGM will be able to benefit people who have had gastric surgery and experience low...
The continuous glucose monitor (CGM) that will be used in this study is already approved by the FDA for monitoring the glucose levels of people with diabetes. The investigators of this study are looking to see if this CGM will be able to benefit people who have had gastric surgery and experience low blood sugar episodes, which can be asymptomatic and lead to complications. This study will involve three to five visits, and involves wearing a sensor and regularly recording blood sugar values and any symptoms experienced as well as a record of treatments for symptoms. This study also involves the use of a fitness tracker, which will be worn for the duration of the 4 weeks of the study and returned at the end of the study. Participants will be able to keep the Dexcom CGM receiver and transmitter.
Tracking Information
- NCT #
- NCT03353415
- Collaborators
- DexCom, Inc.
- Investigators
- Principal Investigator: Mary E Patti, MD Joslin Diabetes Center
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