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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-06008 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (CGM) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive basic diabetes mellitus education |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Dungan, MD, MPH | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Medical Device Usage and Evaluation | Other | Use CGM device and app |
|
| Survey Administration | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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