Hematopoietic and Lymphoid System NeoplasmNCT04938869
Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer
A study testing Educational Intervention, Medical Device Usage and Evaluation and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus
- What is being tested?
- Educational Intervention, Medical Device Usage and Evaluation and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Insulin use > 10 units per day
- Hemoglobin A1c > 8.5%
- Smart phone compatible with LibreView App
Who cannot join
- Type 1 diabetes mellitus (DM)
- Inability to consent
- Pregnancy
- Prisoners
- Discharge to skilled nursing facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus
- Being tested
- Educational Intervention, Medical Device Usage and Evaluation, Survey Administration
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive basic diabetes mellitus education
Medical Device Usage and EvaluationOther
Use CGM device and app
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 4 weeks post-discharge
Secondary outcomes (7)
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.
Measured: From baseline to 2 weeks post-discharge
Overall control
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Measured: Up to 4 weeks post-discharge
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.
Measured: From week 1 to week 4
Number of patients with successful data collection
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Measured: At 2 weeks
Number of patients with successful data collection
Descriptive statistics will summarize the sample characteristics and distribution of each variable.
Measured: At 4 weeks
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.
Measured: From baseline to 4 weeks post-discharge
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.
Measured: Immediately following inpatient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start5 Oct 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Dungan, Ohio State University Comprehensive Cancer Center
- Investigators
- Kathleen M Dungan, MD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938869
- Sponsor's protocol ID
- OSU-21093
- Other IDs
- NCI-2021-06008
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy
- ClinicalTrials.gov ID
- NCT04938869
- Acronym / sponsor ID
- OSU-21093
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (CGM) | Experimental | Other: Educational Intervention, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationPrior 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- Insulin use > 10 units per day
- Hemoglobin A1c > 8.5%
- Smart phone compatible with LibreView App
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus (DM)
- Inability to consent
- Pregnancy
- Prisoners
- Discharge to skilled nursing facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive basic diabetes mellitus education | Other | Supportive care (CGM) |
| Medical Device Usage and EvaluationUse CGM device and app | Other | Supportive care (CGM) |
| Survey AdministrationAncillary studies | Other | Supportive care (CGM) |
Primary outcome
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.
7 secondary outcomes
Change in DTSQ scores
Time frame: From baseline to 2 weeks post-discharge
Overall control
Time frame: Up to 4 weeks post-discharge
Change in various measures of control
Time frame: From week 1 to week 4
Number of patients with successful data collection
Time frame: At 2 weeks
Number of patients with successful data collection
Time frame: At 4 weeks
Change in Patient Health Questionnaire scores
Time frame: From baseline to 4 weeks post-discharge
Incidence of adverse events
Time frame: Immediately following inpatient hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Dungan, MD, MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Medical Device Usage and Evaluation and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) survey score (time frame: From baseline to 4 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.