Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery
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|ClinicalTrials.gov Identifier: NCT03353415|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypoglycemia, Reactive Hypoglycemia||Device: Dexcom continuous glucose monitor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Sequential Assignment|
|Intervention 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.|
|Official Title:||Determining the Efficacy of Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: CGM Use
Each participant will wear the DexCom continuous glucose monitor for four weeks. During the first two weeks, participants will not be able to read the sensor glucose levels. In the second two weeks, participants will be able to read the sensor glucose levels. Frequency of hypoglycemia will be compared between the two phases of the study.
Device: Dexcom continuous glucose monitor
The CGM will monitor sensor glucose levels in all participants. During the first two weeks of the study, participants will be masked to the sensor glucose levels and will need to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks, participants will be 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.
- Reduction in hypoglycemia [ Time Frame: 4 weeks ]The primary outcome will be hypoglycemia frequency and severity in masked vs. unmasked periods of CGM wear, as assessed by: (1) minutes per day <70 mg/dl, (2) minutes per day <55 mg/dl, (3) number of episodes requiring assistance, (4) episodes of severe hypoglycemia (<55 mg/dl), (5) episodes of moderate hypoglycemia (55-70 mg/dl), and (6) nocturnal hypoglycemia (11 PM to 6 AM).
- Impact of lifestyle on glycemic patterns in post-bariatric hypoglycemia [ Time Frame: 4 weeks ]Activity measures, including total step number as well as duration of activity as defined by heart rate increment, will be analyzed to determine relationship to changes in sensor glucose levels. For all data, paired analysis will be used to compare responses per participant for masked vs. unmasked periods (2 weeks each).
- Reduction in glycemic variability [ Time Frame: 4 weeks ]CGM data will be analyzed to evaluate (1) number of episodes of hyperglycemia (>180 mg/dl) and (2) overall variability in glycemia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353415
|Contact: Mary E Patti, MD||(617) firstname.lastname@example.org|
|Contact: Lauren N Richardson, BS||(617) email@example.com|
|United States, Massachusetts|
|Joslin Diabetes Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Mary E Patti, MD 617-309-2635 firstname.lastname@example.org|
|Contact: Lauren N Richardson, BS (617) 309-4463 email@example.com|
|Principal Investigator:||Mary E Patti, MD||Joslin Diabetes Center|