Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04938869
Recruitment Status : Not yet recruiting
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Type 2 Diabetes Mellitus Other: Educational Intervention Other: Medical Device Usage and Evaluation Other: Survey Administration Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive care (CGM)
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
Receive basic diabetes mellitus education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Medical Device Usage and Evaluation
Use CGM device and app

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938869


Contacts
Layout table for location contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
Layout table for location information
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Contact: Kathleen M. Dungan, MD, MPH    800-293-5066      
Principal Investigator: Kathleen M. Dungan, MD, MPH         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Kathleen M Dungan, MD, MPH Ohio State University Comprehensive Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Kathleen Dungan, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04938869    
Other Study ID Numbers: OSU-21093
NCI-2021-06008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases