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Use of CGM for Diabetes Management Following a Hospitalization.

NCT04149392 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-10

No results posted yet for this study

Summary

Patients with diabetes hospitalized for heart failure or acute myocardial infarction will have a continuous glucose monitor (CGM) placed on the day of discharge which will be downloaded at their outpatient follow up clinic visit 6-14 days later. At the follow-up visit medications may be modified based on downloaded glucose data. This study is designed to determine the frequency that patients with diabetes hospitalized for heart failure or acute myocardial infarction have significant hypoglycemia or hyperglycemia requiring medication adjustment in the 1-2 weeks following hospital discharge. The outcome will be a binary- yes, diabetes medications were adjusted or no, diabetes medications were not adjusted.

As a secondary outcome 30-day hospital readmission and mortality will be compared to historical hospital data collected by the inpatient cardiovascular service as part of their quality improvement monitoring. Researchers do not expect to see a significant difference in 30-day readmission or mortality as this study will be under-powered. In addition, our inclusion criteria will specifically target the patients at highest risk for bad diabetes outcomes, thus researchers may see worse outcomes compared to historical controls, but this assessment will help us design future randomized studies.

Conditions

Interventions

DEVICE

Continuous Glucose Monitor

Patients with diabetes hospitalized for heart failure or acute myocardial infarction will have a continuous glucose monitor (CGM) placed on the day of discharge. The participants will go home with the device and keep it for 6-14 days until they return to clinic for follow up visit. At this time the device will be removed, the information regarding glucose levels during those days will be downloaded and based on the download, a PharmD will have the option of increasing or decreasing insulin doses by a maximum of 10% to reduce hypoglycemia and/or hyperglycemia. The goal will be to adjust medications, if needed, to target blood sugars between 90-250mg/dl greater than 80% of the time.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Heather Ferris, MD PhD · University of Virginia

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-04-06
Completion
2020-04-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149392 on ClinicalTrials.gov