Clinical trial NCT04938869: Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer
Official title: Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Type 2 Diabetes Mellitus
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
timeFrame: From baseline to 4 weeks post-discharge
Secondary outcomes:
measure: Change in DTSQ scores
timeFrame: From baseline to 2 weeks post-discharge
measure: Overall control
timeFrame: Up to 4 weeks post-discharge
measure: Change in various measures of control
timeFrame: From week 1 to week 4
measure: Number of patients with successful data collection
timeFrame: At 2 weeks
measure: Number of patients with successful data collection
timeFrame: At 4 weeks
measure: Change in Patient Health Questionnaire scores
timeFrame: From baseline to 4 weeks post-discharge
measure: Incidence of adverse events
timeFrame: Immediately following inpatient hospitalization
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Kathleen M Dungan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: