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Device

Continuous Glucose Monitoring for Low Blood Sugar

N/A

Recruiting

Led By Mary E Patti, MD

Research Sponsored by Joslin Diabetes Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males or females diagnosed with ongoing post-bariatric, post-gastric surgery or other forms of postprandial hypoglycemia with prior episodes of neuroglycopenia

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

Must not have

Hepatic disease, including serum alanine aminotransferase (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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study people with hypoglycemia to see if there is a connection between the makeup of their microbiome and their post-meal blood sugar levels.

Who is the study for?

This trial is for adults aged 18-65 with postprandial hypoglycemia, particularly after bariatric or gastric surgery. Participants must have had episodes of neuroglycopenia and be willing to consent to study procedures. Exclusions include severe kidney disease, substance abuse, recent major surgery, certain heart conditions, liver disease, active cancer (except some skin cancers), seizure disorders unrelated to hypoglycemia, pregnancy/lactation without agreed contraception use.

What is being tested?

The study uses a Dexcom continuous glucose monitor and an activity monitor to investigate the relationship between the gut microbiome and blood sugar levels after eating in people who experience low blood sugar symptoms following meals.

What are the potential side effects?

While not explicitly stated for monitors used in this trial, potential side effects may include skin irritation from adhesive patches of the devices or discomfort at sensor insertion sites. The risk of serious side effects is generally considered low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had low blood sugar episodes after eating due to previous weight loss surgery.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver isn't working properly, shown by high ALT or AST, low albumin, or high bilirubin.

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I have had heart issues or risk factors like diabetes, high blood pressure, high cholesterol, or I smoke.

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I am currently taking β-blocker medication.

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I am taking diabetes medication, but not acarbose.

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I am currently taking octreotide or diazoxide.

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I have had fainting spells not caused by low blood sugar or have a heart rhythm problem.

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I have an active cancer that is not a minor skin cancer.

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I have been diagnosed with insulinoma.

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I do not have a bleeding disorder, am not on warfarin, and my platelet count is above 50,000.

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I have not donated blood in the last 2 months.

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I have a seizure disorder not caused by low blood sugar.

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I or my family have a history of pheochromocytoma or related genetic disorders.

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I have been diagnosed with moderate to severe heart failure.

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I have advanced chronic kidney disease.

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I have had a stroke before.

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I am currently taking steroids in pill form or by injection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analysis of cumulative duration of hypoglycemia

Secondary study objectives

Analysis of frequency of glycemic excursions

Analysis of microbiome in individuals with post-bariatric hypoglycemia

Impact of activity on glycemic patterns in post-bariatric hypoglycemia

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CGM and MicrobiotaExperimental Treatment1 Intervention

Participants will wear a Dexcom continuous glucose monitor (CGM) and activity monitor for two weeks. They will not be aware of sensor glucose values. A stool sample will be collected. The investigators will evaluate relationships between patterns of postprandial glycemia, recorded by CGM, food intake, and microbiome composition.

0 / 18Eligibility criteria met