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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Medical Device Usage and Evaluation
Survey Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (CGM)

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in DTSQ scores
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.
Overall control
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Change in various measures of control
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.
Number of patients with successful data collection
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Number of patients with successful data collection
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Change in Patient Health Questionnaire scores
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.
Incidence of adverse events
Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable.

Full Information

First Posted
June 17, 2021
Last Updated
February 22, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04938869
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (CGM)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive basic diabetes mellitus education
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Use CGM device and app
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score
Description
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.
Time Frame
From baseline to 4 weeks post-discharge
Secondary Outcome Measure Information:
Title
Change in DTSQ scores
Description
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.
Time Frame
From baseline to 2 weeks post-discharge
Title
Overall control
Description
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time Frame
Up to 4 weeks post-discharge
Title
Change in various measures of control
Description
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.
Time Frame
From week 1 to week 4
Title
Number of patients with successful data collection
Description
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time Frame
At 2 weeks
Title
Number of patients with successful data collection
Description
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time Frame
At 4 weeks
Title
Change in Patient Health Questionnaire scores
Description
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.
Time Frame
From baseline to 4 weeks post-discharge
Title
Incidence of adverse events
Description
Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Time Frame
Immediately following inpatient hospitalization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Dungan, MD, MPH
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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