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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938869
• Other study ID #: OSU-21093
• Secondary ID: NCI-2021-06008
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: February 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Educational Intervention
Receive basic diabetes mellitus education
• Medical Device Usage and Evaluation
Use CGM device and app
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall control	Descriptive statistics will summarize the sample characteristics and distribution of each variable.	Up to 4 weeks post-discharge
Secondary	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
Secondary	Number of patients with successful data collection	Descriptive statistics will summarize the sample characteristics and distribution of each variable.	At 2 weeks
Secondary	Number of patients with successful data collection	Descriptive statistics will summarize the sample characteristics and distribution of each variable.	At 4 weeks
Secondary	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
Secondary	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

External Links

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