Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03353415
Study type Interventional
Source Joslin Diabetes Center
Contact
Status Completed
Phase N/A
Start date February 7, 2019
Completion date April 12, 2023

See also
  Status Clinical Trial Phase
Completed NCT03482154 - Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
Completed NCT03667053 - Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children Phase 3
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Recruiting NCT05379686 - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes N/A
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Withdrawn NCT03736083 - Introducing CGM at Type 1 Diabetes Diagnosis N/A
Completed NCT02966275 - Post Bariatric Closed Loop Glucagon Trial N/A
Not yet recruiting NCT02909881 - Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes N/A
Withdrawn NCT02518022 - How to be Safe With Alcoholic Drinks in Diabetes N/A
Completed NCT02213003 - Allogeneic Islet Cells Transplanted Onto the Omentum Phase 1/Phase 2
Completed NCT01147276 - Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes Phase 4
Completed NCT01176656 - Hypoglycemia: Physician and Patient Perspectives N/A
Completed NCT00998374 - Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge N/A
Terminated NCT01225159 - Tight Glycaemic Control During Cardiac Surgery N/A
Completed NCT00373854 - Study of How Low Blood Sugar Affects the Way Blood Vessels Work N/A
Completed NCT00285233 - Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes Phase 1/Phase 2
Recruiting NCT05916131 - Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management. N/A
Terminated NCT04026750 - Insulin Tolerance Test Study in Patients With Type 1 Diabetes Phase 1
Completed NCT05133765 - The SMART B Exercise Study :''The SMART Study'' N/A