N/A
Completed N=25
Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery
Hypoglycemia, Reactive · Hypoglycemia
Source: ClinicalTrials.gov NCT03353415 ↗
Enrolled (actual)
25
Serious AEs
2.1%
Results posted
Aug 2023
Primary outcomePrimary: Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. — 4.7; 2.9 Percentage of time — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time Sensor Glucose <70 mg/dL in the Masked Versus the Unmasked Phase. |
4.7; 2.9 | 0.04 sig |
| PRIMARY Percentage of Time Sensor Glucose <60mg/dL in the Masked Versus the Unmasked Phase |
1.4; 0.7 | 0.03 sig |
| PRIMARY Percentage of Time Sensor Glucose <54 mg/dL in the Masked Versus the Unmasked Phase |
0.6; 0.2 | 0.14 |
| SECONDARY Median Sensor Glucose Level During Masked Versus Unmasked Phases of Wear |
97.5; 97.0 | 0.45 |
| SECONDARY Mean Sensor Glucose Level During Masked Versus Unmasked Phases of Wear |
103.8; 104.1 | 0.35 |
| SECONDARY Peak Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear |
263.0; 256.0 | 0.53 |
| SECONDARY Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear |
221.5; 209.5 | 0.47 |
| SECONDARY Nadir Sensor Glucose Level During Masked Versus Unmasked Period of CGM Wear |
40.0; 42.0 | 0.65 |
| SECONDARY Percent of Time Sensor Glucose 70-180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase |
90.8; 94.8 | 0.004 sig |
| SECONDARY Percentage of Time Sensor Glucose Level >180 mg/dL During Period of CGM Wear, Masked Versus Unmasked Phase |
3.1; 1.7 | 0.05 |
| SECONDARY Percentage of Time Sensor Glucose Level >250 mg/dL During Periods of CGM Wear, Masked Versus Unmasked Phase |
0.1; 0.1 | 0.22 |
| SECONDARY Glycemic Variability as Measured by the Standard Deviation of Sensor Glucose Level Data During Periods of CGM Wear, Masked Versus Unmasked Phase |
29.8; 26.6 | 0.09 |
| SECONDARY Mean Coefficient of Variation of Sensor Glucose Data During Period of CGM Wear, Masked Versus Unmasked Phase |
23.6; 23.0 | 0.25 |
| SECONDARY Mean Amplitude of Glycemic Excursion (MAGE) of Sensor Glucose Levels During Periods of CGM Wear, Masked Versus Unmasked Phase |
79.6; 74.0 | 0.04 sig |
| SECONDARY 24 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase |
35.6; 33.0 | 0.15 |
| SECONDARY 1 Hour Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase |
35.5; 33.2 | 0.03 sig |
| SECONDARY 2 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase |
36.1; 36.9 | 0.04 sig |
| SECONDARY 4 Hours, Continuous Overall Net Glycemic Action (CONGA) for Sensor Glucose Data During Periods of CGM Wear, Masked Versus Unmasked Phase |
38.9; 37.0 | 0.32 |
| 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 |
1.6; 1.8 | 0.41 |
| 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 |
0.7; 0.5 | 0.04 sig |
| 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 |
0.3; 0.2 | 0.08 |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03353415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.