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

Not Applicable

Completed

• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; Type 2 Diabetes Mellitus
• Interventions: Other: Educational Intervention; Other: Medical Device Usage and Evaluation; Other: Survey Administration

• Registration Number: NCT04938869
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-24
• Study Start: 2021-10-05
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (CGM)	Educational Intervention	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.
Supportive care (CGM)	Survey Administration	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.
Supportive care (CGM)	Medical Device Usage and Evaluation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Overall control	Up to 4 weeks post-discharge	Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Number of patients with successful data collection	At 4 weeks	Descriptive statistics will summarize the sample characteristics and distribution of each variable.
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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States