Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hematopoietic and Lymphoid System Neoplasm
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. Patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. Adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate if addition of continuous glucose monitor (CGM) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with DM management in patients with cancer and poorly controlled type 2 diabetes mellitus. SECONDARY OBJECTIVES: I. Evaluate feasibility of CGM initiation upon hospital discharge. II. Evaluate effect of CGM on recognition of post-hospitalization hypoglycemia. III. Evaluate patient reported outcome of CGM incorporation into patient diabetes care burden. IV. Evaluate effect of CGM on depression score before and after CGM use. OUTLINE: Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone application (app). Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.
Investigators
Kathleen Dungan
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Insulin use \> 10 units per day
- •Hemoglobin A1c \> 8.5%
- •Smart phone compatible with LibreView App
Exclusion Criteria
- •Type 1 diabetes mellitus (DM)
- •Inability to consent
- •Pregnancy
- •Prisoners
- •Discharge to skilled nursing facility
Outcomes
Primary Outcomes
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
Time Frame: From baseline to 4 weeks post-discharge
Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.
Secondary Outcomes
- Change in various measures of control(From week 1 to week 4)
- Change in DTSQ scores(From baseline to 2 weeks post-discharge)
- Overall control(Up to 4 weeks post-discharge)
- Number of patients with successful data collection(At 4 weeks)
- Change in Patient Health Questionnaire scores(From baseline to 4 weeks post-discharge)
- Incidence of adverse events(Immediately following inpatient hospitalization)