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 range

18 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 65 Years

Sex

ALL

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

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.