Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes

June 21, 2023 updated by: VA Office of Research and Development

Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia

More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System (GTS), with which glucose values can be wirelessly transmitted from the patient's bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs associated with hospitalization of diabetics in the United States (US). Up to 30% of the hospitalized diabetics develop hypoglycemia, a condition that is associated with higher hospital charges, prolonged length of stay, and increased morbidity and mortality.

Reducing hypoglycemic events in the inpatient setting has led hospitals to develop hypoglycemia prevention policies; policies which are however limited by the infrequent Point of Care (POC) capillary blood glucose testing in the general wards. Continuous Glucose Monitoring (CGM) devices represent additional ways to monitor blood glucose levels. Only a limited number of studies have examined the use of CGM devices in the non-ICU setting. In all these studies, CGM use was found to be superior compared to POC in hypoglycemia detection. However, as the results of CGM were blinded (alarms were turned off) for both the investigators and the participants, interventions to prevent hypoglycemia were not performed. Additionally, one major limitation of CGM technology is that CGM receiver/monitor needs to be located in the patient's room, due to Bluetooth Technology signal-strength restrictions, necessitating nurses to enter frequently the patient's room in order to check CGM glucose values. In the current application, the investigators are going to evaluate whether an innovative system that the investigators call "Glucose Telemetry System" (GTS) can decrease hypoglycemia and improve clinical outcomes in hospitalized Veterans with DM2.

Discovering novel ways to monitor glucose values in the hospital setting could have a significant impact in preventing hypoglycemia in the inpatient setting- a condition that is associated with adverse clinical outcomes. The investigators believe that this proposal is highly innovative. The trial may lead to future wider use of CGM in hospitalized patients with DM who are at a higher risk for hypoglycemia, similar to the way that the investigators use cardiac telemetry for patients who are at an increased risk for developing arrhythmias.

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
        • Contact:
        • Principal Investigator:
          • Ilias Spanakis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans with history of DM2 managed with insulin (either basal bolus, basal only or basal with per os DM medications), admitted to the Baltimore VA Medical Center, who have at

    • least 1 risk factor of hypoglycemia

Exclusion Criteria:

  • Veterans with history of type 1 DM.
  • Veterans with history of DM2 managed with diet or any combination of oral antidiabetic drugs only.
  • Veterans hospitalized with significant hyperglycemia or diabetic ketoacidosis
  • Pregnant Veterans
  • Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day
  • Veterans that are expected to require a hospital stay <3 days will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group (Continuous Glucose Monitroring and POC)
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)
Device: GTS (Continuous Glucose Monitoring)
Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS)
Other: POC (Point of Care)
Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.
Placebo Comparator: Control group (Point of Care-POC)
Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)
Other: POC (Point of Care)
Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in hypoglycemia during the hospitalization
Time Frame: Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)
GTS and the application of the hypoglycemia prevention protocol will lead to a decrease in hypoglycemia in the hospital
Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Ilias Spanakis, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDA-022-17F
  • CX001825-01 (Other Grant/Funding Number: VA Office of Research and Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will willingly share de-identified data to qualified investigators who wish to perform any additional analyses, including validation of results. Researchers need also to have completed Human Subjects and HIPPA training. Data will be provided after the end of the study.

Study findings may also be presented at scientific meetings (such as American Diabetes Association and Diabetes Technology Society meetings). Study findings may also be presented at Medical and Endocrine Grand Rounds nationally. Final data sets (i.e demographic data, medication usage data, glucometric values) will be maintained locally (VABMC server) until enterprise-level resources become available for long term storage and access.

IPD Sharing Time Frame

6 months after the final publication have been submitted (and following the clinical trial completion)

IPD Sharing Access Criteria

Final data sets will be maintained locally until enterprise-level resources become available. Upon request, the investigators will provide a de-identified, anonymized data set to others in the scientific community with the implementation of appropriate data use agreements. Data that can potentially shared are glucometric values and medication usage data. This will allow others to validate the investigators' findings.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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