Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
OTHEREducational Intervention
Receive basic diabetes mellitus education
OTHERMedical Device Usage and Evaluation
Use CGM device and app
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall control | Up to 4 weeks post-discharge | Descriptive statistics will summarize the sample characteristics and distribution of each variable. |
| Change in various measures of control | From week 1 to week 4 | 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. |
| Change in DTSQ scores | From baseline to 2 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. |
| Change in Patient Health Questionnaire scores | 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. |
| Incidence of adverse events | Immediately following inpatient hospitalization | Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable. |
| Number of patients with successful data collection | At 2 weeks | Descriptive statistics will summarize the sample characteristics and distribution of each variable. |
Countries
United States
Outcome results
None listed