Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Educational Intervention
* Other: Medical Device Usage and Evaluation
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (CGM)<br>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 app. Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days. | Other: Educational Intervention<br>* Receive basic diabetes mellitus education<br>* Other names: Intervention, Educational;Other: Medical Device Usage and Evaluation<br>* Use CGM device and app<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score | 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. | From baseline to 4 weeks post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DTSQ scores | 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. | From baseline to 2 weeks post-discharge | 
| Overall control | Descriptive statistics will summarize the sample characteristics and distribution of each variable. | Up to 4 weeks post-discharge | 
| Change in various measures of control | 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. | From week 1 to week 4 | 
| Number of patients with successful data collection | Descriptive statistics will summarize the sample characteristics and distribution of each variable. | At 2 weeks | 
| Number of patients with successful data collection | Descriptive statistics will summarize the sample characteristics and distribution of each variable. | At 4 weeks | 
| Change in Patient Health Questionnaire scores | 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. | From baseline to 4 weeks post-discharge | 
| Incidence of adverse events | Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable. | Immediately following inpatient hospitalization |