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

The continuous glucose monitor (CGM) that will be used in this study is already approved by
the FDA for monitoring the glucose levels of people with diabetes. The investigators of this
study are looking to see if this CGM will be able to benefit people who have had gastric
surgery and experience low blood sugar episodes, which can be asymptomatic and lead to
complications. This study will involve three to five visits, and involves wearing a sensor
and regularly recording blood sugar values and any symptoms experienced as well as a record
of treatments for symptoms. This study also involves the use of a fitness tracker, which will
be worn for the duration of the 4 weeks of the study and returned at the end of the study.
Participants will be able to keep the Dexcom CGM receiver and transmitter.

Inclusion Criteria:

1. Males or females diagnosed with ongoing post-bariatric or post-gastric surgery
hypoglycemia with prior episodes of neuroglycopenia

2. Age 18-65 years of age, inclusive, at screening

3. Willingness to provide informed consent and follow all study procedures, including
attending all scheduled visits.

Exclusion Criteria:

1. Documented hypoglycemia occurring in the fasting state (> 12 hours fast);

2. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);

3. Hepatic disease, including serum ALT or 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;

4. Congestive heart failure, NYHA class II, Ill or IV;

5. 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.

6. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia

7. Concurrent administration of 13-blocker therapy;

8. History of a cerebrovascular accident;

9. Seizure disorder (other than with suspect or documented hypoglycemia);

10. Active treatment with any diabetes medications except for acarbose;

11. Active treatment with octreotide or diazoxide;

12. Active malignancy, except basal cell or squamous cell skin cancers;

13. Personal or family history of pheochromocytoma or disorder with increased risk of
pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);

14. Known insulinoma;

15. Major surgical operation within 30 days prior to screening;

16. Hematocrit< 33%;

17. Bleeding disorder, treatment with warfarin, or platelet count <50,000;

18. Blood donation (1 pint of whole blood) within the past 2 months;

19. Active alcohol abuse or substance abuse;

20. Current administration of oral or parenteral corticosteroids;

21. 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.

22. Use of an investigational drug within 30 days prior to screening