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

The Ohio State University

Status: Completed

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

Treatments: Other: Survey Administration; Other: Medical Device Usage and Evaluation; Other: Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04938869

NCI-2021-06008 (Registry Identifier)

OSU-21093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Supportive care (CGM)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention

Other: Medical Device Usage and Evaluation

Other: Survey Administration