Use of CGM for Diabetes Management Following a Hospitalization.

NCT04149392 | Withdrawn

• 1 other identifier: 15055
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Diabetes

Keywords

CGM Diabetes Heart Failure

Outcome Measures

Primary Outcomes (1)

• Frequency of diabetes medication changes that take place at the follow up visit

  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 Outcomes (2)

• 30-day Readmission rate

  30 days after hospital discharged

• Mortality rate

  30-40 days after hospital discharged

Study Arms (1)

CGM intervention

EXPERIMENTAL

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

Interventions

Continuous Glucose Monitor DEVICE

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.

CGM intervention

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (6)

• Dungan K, Graessle K, Sagrilla C. The effect of congestive heart failure on sensor accuracy among hospitalized patients with type 2 diabetes. Diabetes Technol Ther. 2013 Oct;15(10):817-24. doi: 10.1089/dia.2013.0094.

  PMID: 24050738 BACKGROUND

• Tung YC, Chang GM, Chang HY, Yu TH. Relationship between Early Physician Follow-Up and 30-Day Readmission after Acute Myocardial Infarction and Heart Failure. PLoS One. 2017 Jan 27;12(1):e0170061. doi: 10.1371/journal.pone.0170061. eCollection 2017.

  PMID: 28129332 BACKGROUND

• Dei Cas A, Khan SS, Butler J, Mentz RJ, Bonow RO, Avogaro A, Tschoepe D, Doehner W, Greene SJ, Senni M, Gheorghiade M, Fonarow GC. Impact of diabetes on epidemiology, treatment, and outcomes of patients with heart failure. JACC Heart Fail. 2015 Feb;3(2):136-45. doi: 10.1016/j.jchf.2014.08.004.

  PMID: 25660838 BACKGROUND

• Ruppar TM, Cooper PS, Mehr DR, Delgado JM, Dunbar-Jacob JM. Medication Adherence Interventions Improve Heart Failure Mortality and Readmission Rates: Systematic Review and Meta-Analysis of Controlled Trials. J Am Heart Assoc. 2016 Jun 17;5(6):e002606. doi: 10.1161/JAHA.115.002606.

  PMID: 27317347 BACKGROUND

• Bergethon KE, Ju C, DeVore AD, Hardy NC, Fonarow GC, Yancy CW, Heidenreich PA, Bhatt DL, Peterson ED, Hernandez AF. Trends in 30-Day Readmission Rates for Patients Hospitalized With Heart Failure: Findings From the Get With The Guidelines-Heart Failure Registry. Circ Heart Fail. 2016 Jun;9(6):10.1161/CIRCHEARTFAILURE.115.002594 e002594. doi: 10.1161/CIRCHEARTFAILURE.115.002594.

  PMID: 27301467 BACKGROUND

• Bilchick K, Moss T, Welch T, Levy W, Stukenborg G, Lawlor BT, Reigle J, Thomas SC, Brady C, Bergin JD, Kennedy JLW, Abuannadi M, Scully K, Mazimba S. Improving Heart Failure Readmission Costs and Outcomes With a Hospital-to-Home Readmission Intervention Program. Am J Med Qual. 2019 Mar/Apr;34(2):127-135. doi: 10.1177/1062860618788436. Epub 2018 Jul 19.

  PMID: 30024279 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Heather Ferris, MD PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician scientist

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: December 16, 2019
• Primary Completion: April 6, 2020
• Study Completion: April 6, 2020
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share