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

NCT03353415 | Completed Results FDA Device

• 1 other identifier: 2017-27
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 severity of low blood sugar episodes.

Conditions

Hypoglycemia, Reactive; Hypoglycemia

Keywords

Post-bariatric Hypoglycemia;

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (18)

• 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.

• 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.

• Peak 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.

• Sensor Glucose Level Range (Highest Sensor Glucose Minus Lowest Sensor Glucose mg/dL) During Masked Versus Unmasked Period of CGM Wear

  28 days for those participants wearing Dexcom G4, and 20 days for participants wearing Dexcom G6.

• 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.

Study Arms (2)

Masked CGM Wear (Phase 1)

OTHER

Each participant will wear the Dexcom CGM for two sequential phases. During the first phase, participants will not be able to read the sensor glucose levels (masked).

Device: Dexcom CGM masked

Unmasked CGM Wear (Phase 2)

EXPERIMENTAL

In the second phase, participants will be able to read the sensor glucose levels (unmasked). Frequency of hypoglycemia will be compared between the two phases of the study.

Device: Dexcom CGM unmasked

Interventions

Dexcom CGM masked DEVICE

The CGM will monitor sensor glucose levels in all participants. (Initially the Dexcom G4 was worn by participants (n=13); however, when the G4 became unavailable, the G6 was worn by the subsequent participants (n=10)). The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).

Masked CGM Wear (Phase 1)

Dexcom CGM unmasked DEVICE

During the second phase (2 weeks for the Dexcom G4 and 10 days for the Dexcom G6), participants are able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop. The duration of the Dexcom G4 sensor was 7 days (2 sensors placed during each phase of participation) versus the Dexcom G6 whose sensor duration is 10 days (1 sensor placed during each phase of participation).

Unmasked CGM Wear (Phase 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• 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.

  PMID: 26701701 BACKGROUND

• 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):2191-2202. doi: 10.1111/dom.15096. Epub 2023 May 3.

  PMID: 37046360 RESULT

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Mary Elizabeth Patti, MD
• Organization: Joslin Diabetes Center

MaryElizabeth.Patti@Joslin.Harvard.edu

6713092635

Study Officials

• Mary Elizabeth Patti, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Participants themselves will not be masked to study design. The only masking will be of the device sensor glucose data during the first 2 weeks (Dexcom G4) or 10 days (Dexcom G6) of the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study is designed to assess the efficacy of unmasked personal CGM to reduce the frequency of hypoglycemia after gastric surgery. Specifically, we will analyze glycemic patterns during a phase of baseline masked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6), in comparison to a sequential, second phase of unmasked CGM wear (2 weeks for the Dexcom G4 or 10 days for the Dexcom G6). Please note that we have chosen to have a consistent masked monitoring first, as providing unmasked data to participants first could alter their dietary or other patterns and reduce ability of the study to independently assess efficacy of the CGM intervention.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: February 7, 2019
• Primary Completion: November 11, 2021
• Study Completion: April 12, 2023
• Last Updated: August 28, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)