Sponsor study identifier
interventional
26
1 country
1
Study Start
February 7, 2019
Actual (reported)Primary Completion
November 11, 2021
Actual (reported)Study Completion
April 12, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 12, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2017
Actual (reported)November 27, 2017
Actual (reported)February 7, 2019
Actual (reported)November 11, 2021
Actual (reported)April 12, 2023
Actual (reported)August 14, 2023
Actual (reported)Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<70 mg/dl, comparing the masked versus the unmasked phases.
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase
The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is \<60 mg/dl, comparing the masked versus the unmasked phases.
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear
28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.
Each participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked).
In the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study.
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).
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available.
Cummings C, Jiang A, Sheehan A, Ferraz-Bannitz R, Puleio A, Simonson DC, Dreyfuss JM, Patti ME. Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Diabetes Obes Metab. 2023 Aug;25(8):2191-2202. doi: 10.1111/dom.15096. Epub 2023 May 3.
Mary Elizabeth Patti, MD
Joslin Diabetes Center
26 participants (actual enrollment reported by the registry).
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Submitted
November 21, 2017
First Posted
November 27, 2017
Study Start
February 7, 2019
Actual (reported)Primary Completion
November 11, 2021
Actual (reported)Study Completion
April 12, 2023
Actual (reported)Last Updated
August 28, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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