An interventional study of Educational Intervention and Medical Device Usage and Evaluation in Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm and Type 2 Diabetes Mellitus, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 3 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Medical Device Usage and Evaluation · Other: Survey Administration
Receive basic diabetes mellitus education
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Use CGM device and app
Ancillary studies
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.
Time frame: From baseline to 4 weeks post-discharge
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.
Time frame: From baseline to 2 weeks post-discharge
Overall control
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time frame: 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.
Time frame: 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.
Time frame: At 2 weeks
Number of patients with successful data collection
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time frame: 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.
Time frame: 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.
Time frame: Immediately following inpatient hospitalization
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center