Use of CGM for Diabetes Management Following a Hospitalization.

December 6, 2019 updated by: Heather Ferris, University of Virginia

Pilot Study for the Use of CGM for Post-discharge Diabetes Management Following a Hospitalization for Heart Failure or MI

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

After the participant has signed the consent form a continuous glucose monitor (CGM) sensor will be placed on the arm of the participant. If consent is signed prior to the day of discharge the sensor placement will be delayed until the day of discharge. The participant will be provided with instruction to avoid bumping the sensor and to avoid dislodging when bathing and dressing. If the sensor should fall off before the follow up appointment, they will be instructed to bring it with them for a partial download.

During the already scheduled post-discharge follow up appointment the CGM sensor data will be downloaded by clinic staff. The diabetes medications will be reconciled, and the downloaded data will be reviewed with the patient. 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. This is a conservative goal aimed at reducing risk for severe hypo or hyperglycemia with good glycemic control rather than to target tight glycemic control. If adjustment of oral agents or a change of greater than 10% is required this will be done in consultation with an attending physician.

These adjustments will follow standards of care and the expectation is that this will benefit the patient. All changes will be communicated to the participant's primary care physician (PCP) or endocrinologist. If the patient does not have an endocrinologist and it is felt that significant adjustments will be required over time to improve the participant's glucose control they will be given the option of a referral to the Diabetes Cardiovascular Clinic, General Endocrinology Clinic, or if having excessive hypoglycemia the Diabetes Technology Clinic for consideration for long term use of CGM. If no changes are required, this will also be communicated to the patient's PCP or endocrinologist. The downloaded data from the CGM will be scanned in the media tab in the electronic medical record and any adjustments will be included as part of the medical record.

Between 30 and 40 days post-discharge the participant's medical record will be accessed again. At this point it will be determined if the patient was readmitted to the hospital or died in the 30 days post-discharge. In addition, clinic notes will be examined to determine if there is any evidence that the patient developed worsening hypoglycemia or worsening hyperglycemia in response to medication adjustments made during the post-discharge clinic. This data will be collected to assist in understanding the efficacy of the intervention and to ensure that the intervention is not causing unintended harm. This access of the medical record would not be expected to benefit the patient but could provide benefit to future participants or patients.

Study Type

Interventional

Phase

  • Not Applicable

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

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40-100 years.
  • Admitted to either the heart failure or acute coronary service.
  • Followed by the cardiovascular diabetes service for at least 1 day during hospital admission.
  • Planned follow up in either the UVA heart failure readmission clinic or the ACS readmission clinic in 6-14 days post-discharge.
  • Use of insulin, a sulfonylurea, or evidence of poor diabetes control prior to admission.

Exclusion Criteria:

  • Non-English speaking.
  • Pregnant.
  • Requiring dialysis.
  • Lymphedema of both arms.
  • Current CGM use.
  • Plan for CT-scan, MRI or diathermy treatment within 14 days of discharge.
  • Patients taking high dose vitamin C supplements (multivitamin is ok).
  • Patients taking more than 325mg of aspirin daily.
  • Discharge to skilled nursing facility or acute rehab.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM intervention
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. During the already scheduled post-discharge follow up appointment the CGM sensor data will be downloaded by clinic staff. The diabetes medications will be reconciled and the downloaded data will be reviewed with the patient. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of diabetes medication changes that take place at the follow up visit
Time Frame: this will happen between the time of enrollment and the follow up clinic visit 6-14 days after enrollment.
We will determine the frequency of diabetes medication changes that take place at the follow up visit.
this will happen between the time of enrollment and the follow up clinic visit 6-14 days after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day Readmission rate
Time Frame: 30 days after hospital discharged
Researchers will determine the 30-day readmission rate for participants.
30 days after hospital discharged
Mortality rate
Time Frame: 30-40 days after hospital discharged
Researchers will determine the mortality rate for participants.
30-40 days after hospital discharged

Collaborators and Investigators

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

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Heather Ferris, MD PhD, University of Virginia

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 (Anticipated)

December 16, 2019

Primary Completion (Anticipated)

April 6, 2020

Study Completion (Anticipated)

April 6, 2020

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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