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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of cumulative duration of hypoglycemia
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Joslin Diabetes CenterLead Sponsor
96 Previous Clinical Trials
26,546 Total Patients Enrolled
Mary E Patti, MDPrincipal InvestigatorJoslin Diabetes Center
2 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Dexcom continuous glucose monitor and activity monitor (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03385707 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Sep 2024