Diabetes Mellitus, Type 2NCT01715649
Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes
A study testing Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Sutter Health at 1 site in United States.
Trial summary
Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2014
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in diabetes disease management program
- ages 30-70
- HbA1c between 7.5% and 10.9% in the previous six months
- an Internet or 3G connection and email address;
- a working phone line (land line or cellular); and
- ability to read and understand the English language.
Who cannot join
- taking insulin;
- inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment);
- severe complications, which would preclude achieving an HbA1c goal of 7% including diagnosis of the following:
- severe stroke;
- heart failure;
- end-stage renal disease;
- kidney dialysis; and
- legally blind.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated
Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. The investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators.
The purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. Some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. At the end of the study, every participant will be asked questions about how they feel about their health care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose
- Keywords
- Type 2 diabetes, self-management, remote patient monitoring
- 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.
Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucoseBehavioural
In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.
| Study group | Role | What they receive |
|---|---|---|
| Control-usual care | No intervention | Nurse care coordination in a telephonic diabetes disease management program |
| Intervention paired testing and remote monitoring | Experimental | Telehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR Receives: Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Lab test
Measured: Change from baseline to 6 months
Secondary outcomes (3)
Empowerment
Diabetes Empowerment Scale completed by survey
Measured: Change from baseline to 3 months
Behavior Change
Summary of Diabetes Self-Care Behaviors scale completed by survey
Measured: Change from baseline to 3 months
Knowledge
Michigan Diabetes Knowledge Test completed by survey
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sutter Health
- Sponsor type
- University, hospital or other
- Collaborators
- LifeScan, GE Healthcare, University of California, Davis
- Responsible party
- Principal investigator, Deborah Greenwood, Sutter Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715649
- Sponsor's protocol ID
- 1208042ex
- Status last verified
- Nov 2014
- First submitted
- 20 Oct 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes. J Med Internet Res. 2015 Jul 21;17(7):e178. doi: 10.2196/jmir.4112.
PubMed 26199142
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated
- ClinicalTrials.gov ID
- NCT01715649
- Acronym / sponsor ID
- 1208042ex
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, self-management, remote patient monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sutter HealthUniversity, hospital or other
- Collaborators
- LifeScan, GE Healthcare, University of California, Davis
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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.
Telehealth remote patient monitoring is a means of using communications technology - such as telephones, computers, and the Internet - to connect patients remotely with their healthcare team from their homes. The investigators hope to learn more about improving healthy behaviors and blood glucose among persons with diabetes using telehealth remote patient monitoring technology to connect directly with nurse care coordinators.
The purpose of this study is to evaluate a process for improving blood glucose and healthy behaviors among people with type 2 diabetes using telehealth remote patient monitoring technology with nurse care coordinators. Some of the people in this study will work with a nurse care coordinator who will review your blood glucose weekly and call you at home every month for 3 months, while some of the people in this study will simply receive their normal care. At the end of the study, every participant will be asked questions about how they feel about their health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-usual care | No intervention | –Nurse care coordination in a telephonic diabetes disease management program |
| Intervention paired testing and remote monitoring | Experimental | Behavioral: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucoseTelehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Enrolled in diabetes disease management program
- ages 30-70
- HbA1c between 7.5% and 10.9% in the previous six months
- an Internet or 3G connection and email address;
- a working phone line (land line or cellular); and
Key exclusion criteria (8 listed)
- taking insulin;
- inability to independently engage in self-management behaviors (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment);
- severe complications, which would preclude achieving an HbA1c goal of 7% including diagnosis of the following:
- severe stroke;
- heart failure;
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 |
|---|---|---|
| Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucoseIn the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose. | Behavioural | Intervention paired testing and remote monitoring |
Primary outcome
Hemoglobin A1c
Time frame: Change from baseline to 6 months
Lab test
3 secondary outcomes
Empowerment
Time frame: Change from baseline to 3 months
Behavior Change
Time frame: Change from baseline to 3 months
Knowledge
Time frame: Change from baseline to 3 months
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 18 Nov 2014.
- Derived from this study: PubMed 26199142Greenwood DA, Blozis SA, Young HM, Nesbitt TS, Quinn CC. Overcoming Clinical Inertia: A Randomized Clinical Trial of a Telehealth Remote Monitoring Intervention Using Paired Glucose Testing in Adults With Type 2 Diabetes. J Med Internet Res. 2015 Jul 21;17(7):e178. doi: 10.2196/jmir.4112.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Sutter Health 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 6 inclusion and 8 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 18 Nov 2014. 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?
Hemoglobin A1c (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715649, which also lists 1 linked publication.
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 18 Nov 2014.