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

NCT04938869 | Completed DMC

• 2 other identifiers: OSU-21093NCI-2021-06008
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in DTSQ scores

  From baseline to 2 weeks post-discharge

• Overall control

  Up to 4 weeks post-discharge

• Change in various measures of control

  From week 1 to week 4

• Number of patients with successful data collection

  At 2 weeks

• Number of patients with successful data collection

  At 4 weeks

Study Arms (1)

Supportive care (CGM)

EXPERIMENTAL

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

Interventions

Educational Intervention OTHER

Receive basic diabetes mellitus education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive care (CGM)

Medical Device Usage and Evaluation OTHER

Use CGM device and app

Supportive care (CGM)

Survey Administration OTHER

Ancillary studies

Supportive care (CGM)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Insulin use \> 10 units per day
• Hemoglobin A1c \> 8.5%
• Smart phone compatible with LibreView App

You may not qualify if:

• Type 1 diabetes mellitus (DM)
• Inability to consent
• Pregnancy
• Prisoners
• Discharge to skilled nursing facility

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Kathleen M Dungan, MD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 24, 2021
• Study Start: October 5, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)