CompletedNot Applicable

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

United States26 participantsStarted 2019-02-07

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females diagnosed with ongoing post-bariatric or post-gastric surgery hypoglycemia with prior episodes of neuroglycopenia
✓. Age 18-65 years of age, inclusive, at screening
✓. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion criteria

✕. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
✕. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
✕. Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \>2.0;
✕. Congestive heart failure, New York Heart Association (NYHA) class II, Ill or IV;
✕. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
✕. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
✕. Concurrent administration of beta-blocker therapy;
✕. History of a cerebrovascular accident;

What they're measuring

Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.

Timeframe: 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

Timeframe: 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

Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

Trial details

NCT IDNCT03353415

SponsorJoslin Diabetes Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-11

Results submitted2023-06-05

View on ClinicalTrials.gov More Hypoglycemia, Reactive trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males or females diagnosed with ongoing post-bariatric or post-gastric surgery hypoglycemia with prior episodes of neuroglycopenia
✓. Age 18-65 years of age, inclusive, at screening
✓. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

Exclusion criteria

✕. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
✕. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
✕. Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \>2.0;
✕. Congestive heart failure, New York Heart Association (NYHA) class II, Ill or IV;
✕. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
✕. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
✕. Concurrent administration of beta-blocker therapy;
✕. History of a cerebrovascular accident;

What they're measuring

Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase.

Timeframe: 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

Timeframe: 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

Timeframe: 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.