Hypoglycemia Clinical Trial
Official title:
Determining the Efficacy of Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety in Patients With Hypoglycemia After Gastric Surgery
NCT number | NCT03353415 |
Other study ID # | 2017-27 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 7, 2019 |
Est. completion date | April 12, 2023 |
Verified date | August 2023 |
Source | Joslin Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | April 12, 2023 |
Est. primary completion date | November 11, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 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; 4. Congestive heart failure, New York Heart Association (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 beta-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 (multiple endocrine neoplasia (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. |
Country | Name | City | State |
---|---|---|---|
United States | Joslin Diabetes Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Joslin Diabetes Center | DexCom, Inc. |
United States,
Cummings C, Jiang A, Sheehan A, Ferraz-Bannitz R, Puleio A, Simonson DC, Dreyfuss JM, Patti ME. Continuous glucose monitoring in patients with post-bariatric hypoglycaemia reduces hypoglycaemia and glycaemic variability. Diabetes Obes Metab. 2023 Aug;25(8 — View Citation
Patti ME, Goldfine AB. The rollercoaster of post-bariatric hypoglycaemia. Lancet Diabetes Endocrinol. 2016 Feb;4(2):94-6. doi: 10.1016/S2213-8587(15)00460-X. Epub 2015 Dec 15. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <70 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Primary | Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Primary | Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase | The primary outcome will be time spent in hypoglycemic glucose range as measured by percent time sensor glucose is <60 mg/dl, comparing the masked versus the unmasked phases. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | expressed as median and median standard deviation | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear | The sensor glucose level range is derived from the difference between the highest sensor glucose levels minus the lowest sensor glucose level (mg/dL). | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | 24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | CONGA assesses glucose variability within a predetermined time window - 24 hours in this case. Calculation of this parameter is based on the assessment of the differences between glucose values measured at regular time intervals, then on the standard deviation (SD) of these differences | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | 1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | 2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | 4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | ||
Secondary | Total Number of Hypoglycemic Events During the Masked Versus the Unmasked Phases of CGM Wear, as Defined by a Sensor Glucose <70 mg/dL, for at Least 15 Minutes | Hypoglycemic events are defined as having glucose <70 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | Total Number of Hypoglycemic Events Defined by a Sensor Glucose <60 mg/dL, for at Lease 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <60 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. | |
Secondary | Total Number of Hypoglycemic Events Defined by a Sensor Glucose <54 mg/dL, for at Least 15 Minutes, During the Masked Versus Unmasked CGM Phase | Hypoglycemic events are defined as having glucose <54 mg/dL for at least 15 minutes, ending when glucose > the threshold. Hypoglycemic event values were normalized by dividing the number of events by the number of days of data. | 28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6. |
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