Status:
COMPLETED
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Hypoglycemia, Reactive
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 sever...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
- Seizure disorder (other than with suspect or documented hypoglycemia);
- Active treatment with any diabetes medications except for acarbose;
- Active treatment with octreotide or diazoxide;
- Active malignancy, except basal cell or squamous cell skin cancers;
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (multiple endocrine neoplasia (MEN) 2, neurofibromatosis, or Von Hippel-Lindau disease);
- Known insulinoma;
- Major surgical operation within 30 days prior to screening;
- Hematocrit\< 33%;
- Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
- Blood donation (1 pint of whole blood) within the past 2 months;
- Active alcohol abuse or substance abuse;
- Current administration of oral or parenteral corticosteroids;
- Pregnancy and/ or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study. Acceptable contraception includes birth control pill/patch I vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Use of an investigational drug within 30 days prior to screening.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03353415
Start Date
February 7 2019
End Date
April 12 2023
Last Update
August 28 2023
Active Locations (1)
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1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215