Continuous Glucose Monitoring for Low Blood Sugar

ME
LN
Overseen ByLauren N Richardson, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the relationship between gut bacteria and blood sugar levels after meals, particularly for individuals experiencing low blood sugar symptoms post-eating. Participants will use a Dexcom continuous glucose monitor to track blood sugar levels and an activity tracker for two weeks. Researchers will study gut bacteria using a stool sample. Ideal participants are those who have undergone stomach surgery and experience low blood sugar symptoms after meals.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve the management of post-meal blood sugar issues.

Do I need to stop taking my current medications to join the trial?

The trial requires that you stop taking certain medications, such as diabetes medications (except acarbose), β-blockers, octreotide, diazoxide, and corticosteroids. If you are on any of these, you would need to stop them to participate.

What prior data suggests that this continuous glucose monitoring is safe for individuals with hypoglycemia?

Research has shown that the Dexcom continuous glucose monitor (CGM) is generally safe. Studies have found no serious health problems linked to the Dexcom G7 CGM, indicating that users did not experience major health issues from it.

The Dexcom CGM provides accurate, real-time blood sugar readings. However, users should be aware that factors such as taking medications with acetaminophen (a common pain reliever) or being near strong magnets might affect its accuracy. Despite these factors, the device is well-tolerated and offers a helpful way to monitor blood sugar levels.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of Dexcom continuous glucose monitors (CGM) to potentially improve our understanding of low blood sugar management. Unlike traditional methods that rely on periodic blood tests, the CGM provides continuous data on glucose levels without the participant being aware of the readings. This could reveal more precise patterns in blood sugar fluctuations, especially after meals. Additionally, the integration of microbiome analysis through stool samples could offer insights into how gut bacteria might influence blood sugar levels, paving the way for more personalized treatment strategies.

What evidence suggests that this continuous glucose monitoring is effective for low blood sugar?

Studies have shown that using a Dexcom continuous glucose monitor (CGM) can greatly reduce instances of low blood sugar, also known as hypoglycemia. For example, one study found that people using Dexcom CGMs experienced 72% fewer episodes of low blood sugar. Another study demonstrated that using a CGM led to an average 1% drop in A1C levels, which measure long-term blood sugar. The evidence strongly suggests that CGMs help control blood sugar and lower the risk of severe low blood sugar. In this trial, participants will wear a Dexcom CGM and activity monitor to evaluate relationships between patterns of postprandial glycemia, food intake, and microbiome composition. These findings are promising for those seeking to manage hypoglycemia more effectively.678910

Who Is on the Research Team?

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Mary E Patti, MD

Principal Investigator

Joslin Diabetes Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits
I have had low blood sugar episodes after eating due to previous weight loss surgery.

Exclusion Criteria

My liver isn't working properly, shown by high ALT or AST, low albumin, or high bilirubin.
You are currently abusing alcohol or drugs.
I have had heart issues or risk factors like diabetes, high blood pressure, high cholesterol, or I smoke.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a Dexcom continuous glucose monitor and activity monitor for two weeks, and provide a stool sample for microbiome analysis

2 weeks
1 visit (in-person) for initial setup, continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexcom continuous glucose monitor and activity monitor

Trial Overview

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.

How Is the Trial Designed?

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Treatment groups

Experimental Treatment

Group I: CGM and MicrobiotaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joslin Diabetes Center

Lead Sponsor

Trials
98
Recruited
26,500+

Citations

Dexcom CGM Study: 72% Decrease in Hypoglycemia

HypoDE study shows that Dexcom CGM use significantly reduces hypoglycemia in MDI-treated patients with T1D at high risk for hypoglycemia.

The Effectiveness of Continuous Glucose Monitoring Devices ...

CGM demonstrated improved outcomes in T1DM with lower HbA1c and reduced severe hypoglycemia, while in T2DM, CGM significantly lowered HbA1c ...

Six-Month Results Using Continuous Glucose Monitoring ...

Participants using a glucose sensor (n=237) showed clinically meaningful and statistically significant (p<0.001) decrease in A1C of 2.4%+1.9% at 6 months.

Clinical Evidence - Dexcom CGM Improves Glucose Control

Overall: an average 1% A1C reduction after 24 weeks of regular use, compared to baseline (difference of 0.6% compared to SMBG group [p-value <.001]). This ...

Continuous Glucose Monitoring to Reduce Hypoglycemia ...

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 ...

Safety Information

Taking medications with paracetamol/acetaminophen while wearing the Dexcom G5 Mobile CGM System may inaccurately raise the glucose readings generated by the ...

Safety Information

The magnetic fields and heat could damage the components of the Dexcom G5 Mobile CGM System, which may cause it to display inaccurate blood glucose readings or ...

FDA - Summary of Safety and Effectiveness Data (SSED)

Patients may rely on the CGM to alert them to low or high glucose levels rather than using blood glucose values from a meter. There is also a risk that patients ...

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dexcom.com

dexcom.com/en-us

Dexcom Continuous Glucose Monitoring - The most accurate ...

Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results.

Accuracy and Safety of Dexcom G7 Continuous Glucose ...

No serious adverse events were reported. Conclusions: The G7 CGM provides accurate glucose readings with single-digit MARD with arm or abdomen placement in ...