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NCT Number: NCT04938869

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

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.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Malignant Solid Neoplasm Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive basic diabetes mellitus education

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Medical Device Usage and Evaluation

Other

Use CGM device and app

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score

    Time frame: 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 outcomes

  1. Change in DTSQ scores

    Time frame: 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.

  2. Overall control

    Time frame: Up to 4 weeks post-discharge

    Descriptive statistics will summarize the sample characteristics and distribution of each variable.

  3. Change in various measures of control

    Time frame: 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.

  4. Number of patients with successful data collection

    Time frame: At 2 weeks

    Descriptive statistics will summarize the sample characteristics and distribution of each variable.

  5. Number of patients with successful data collection

    Time frame: At 4 weeks

    Descriptive statistics will summarize the sample characteristics and distribution of each variable.

  6. Change in Patient Health Questionnaire scores

    Time frame: 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.

  7. Incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2021
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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