What side effects are associated with this type of intervention?

Common treatments for low blood sugar include glucose tablets, gels, and intravenous glucose administration. Enhanced monitoring systems like the Glucose Telemetry System aim to reduce hypoglycemia by providing real-time glucose data. Known side effects of these treatments can include rebound hyperglycemia, gastrointestinal discomfort, and potential allergic reactions to the glucose products. Continuous glucose monitoring systems may also cause skin irritation or infection at the sensor site. Overall, these treatments are generally well-tolerated and effective in managing hypoglycemia.

What prior FDA approvals exist?

The FDA has approved several treatments for low blood sugar (hypoglycemia), including glucagon injections and nasal sprays, which are used to quickly raise blood glucose levels in emergency situations. While the Glucose Telemetry System (GTS) is a novel approach focusing on wireless transmission of glucose values to enhance monitoring and reduce hypoglycemia, similar FDA-approved technologies include continuous glucose monitoring (CGM) systems. These CGM systems, often used in conjunction with insulin pumps, provide real-time glucose readings and alerts to help manage and prevent hypoglycemia. Although not identical, these technologies share the goal of improving glucose control and reducing the risk of hypoglycemia through advanced monitoring.

What other types of research exist?

Promising alternatives to the Glucose Telemetry System for low blood sugar patients include: 1) Hybrid Closed-Loop Insulin Delivery Systems, which use interstitial glucose sensing, subcutaneous insulin pumps, and sophisticated algorithms to automate insulin delivery; 2) Continuous Glucose Monitoring (CGM) devices, which provide real-time glucose readings and alerts; and 3) Telemedicine interventions, which offer remote monitoring and management of diabetes, potentially improving glycemic control and reducing hypoglycemia.

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Continuous Glucose Monitoring for Diabetes

N/A

Recruiting

Led By Ilias Spanakis, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Veterans with history of type 1 DM

Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion-hospitalization (average length of stay at the hospital of 4-6 days)

Summary

This trial is testing a new system called the Glucose Telemetry System (GTS) that sends blood sugar levels from a patient's bedside to a monitor at the nurse's station. It aims to help hospitalized Veterans with diabetes by preventing dangerously low blood sugar levels. The system allows nurses to keep track of patients' blood sugar without entering the room often. A new system has been developed to monitor blood sugar levels in diabetic patients.

Who is the study for?

This trial is for Veterans with type 2 diabetes managed with insulin, admitted to the Baltimore VA Medical Center, and have at least one risk factor for low blood sugar. It's not for those staying in the hospital less than 3 days, pregnant women, diet-managed diabetics, type 1 diabetics or those on high-dose steroids.

What is being tested?

The study tests a new Glucose Telemetry System (GTS) that wirelessly sends glucose levels from a patient's bedside to a monitor at the nursing station. The aim is to reduce low blood sugar incidents and improve outcomes in hospitalized diabetic patients.

What are the potential side effects?

Since this trial involves monitoring devices rather than medications, traditional side effects are minimal. However, there may be discomfort or skin irritation where the device attaches to the body.

Eligibility Criteria

Exclusion Criteria

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

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I am a veteran with type 1 diabetes.

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I am a veteran taking steroids equivalent to 20 mg of hydrocortisone daily.

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I am a veteran with type 2 diabetes managed without insulin.

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I am a veteran hospitalized due to very high blood sugar or diabetic ketoacidosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion-hospitalization (average length of stay at the hospital of 4-6 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion-hospitalization (average length of stay at the hospital of 4-6 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion-hospitalization (average length of stay at the hospital of 4-6 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Decrease in hypoglycemia during the hospitalization

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Intervention group (Continuous Glucose Monitroring and POC)Active Control2 Interventions

Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms)

Group II: Control group (Point of Care-POC)Placebo Group1 Intervention

Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for low blood sugar include the administration of fast-acting carbohydrates (such as glucose tablets or juice), glucagon injections, and continuous glucose monitoring (CGM) systems. Fast-acting carbohydrates quickly raise blood glucose levels by providing an immediate source of sugar that the body can absorb. Glucagon injections stimulate the liver to release stored glucose into the bloodstream. Continuous glucose monitoring systems, like the Glucose Telemetry System (GTS), provide real-time glucose readings, allowing for timely interventions to prevent hypoglycemia. These treatments are crucial for patients with low blood sugar as they help to quickly restore normal glucose levels and prevent severe complications such as seizures, cardiac arrhythmias, and death.