Type 2 DiabetesTREATNCT01339208
TREAT (Telemedicine for Reach, Education, Access, and Treatment)
A study testing Telemedicine diabetes intervention in people with Type 2 Diabetes, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Telemedicine diabetes intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older with type 2 diabetes
- Referral by a primary care provider.
- HbA1c equal or greater than 7.0%.
Who cannot join
- Type 1 diabetes
- Gestational Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.
Read the detailed description
This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia
- Conditions
- Type 2 Diabetes
- Being tested
- Telemedicine diabetes intervention
- Keywords
- Type 2 Diabetes
- 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.
Telemedicine diabetes interventionOther
3 month duration telemedicine consultation and diabetes education
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Diabetes Intervention | Experimental | Not described Receives: Other: Telemedicine diabetes intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c % from baseline
Measured: 3 and 6 month
Secondary outcomes (1)
Patient satisfaction
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2015
- Study completionMar 2015
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Linda Siminerio, University of Pittsburgh
- Investigators
- Frederico Toledo, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339208
- Sponsor's protocol ID
- PRO10100547
- Acronym
- TREAT
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Toledo FG, Ruppert K, Huber KA, Siminerio LM. Efficacy of the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model for diabetes care. Diabetes Care. 2014 Aug;37(8):e179-80. doi: 10.2337/dc13-1909. No abstract available.
PubMed 25061149
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAT (Telemedicine for Reach, Education, Access, and Treatment)
- ClinicalTrials.gov ID
- NCT01339208
- Acronym / sponsor ID
- TREAT / PRO10100547
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Apr 2011 (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.
The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.
Detailed description
This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Diabetes Intervention | Experimental | Other: Telemedicine diabetes intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older with type 2 diabetes
- Referral by a primary care provider.
- HbA1c equal or greater than 7.0%.
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Gestational Diabetes
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 |
|---|---|---|
| Telemedicine diabetes intervention3 month duration telemedicine consultation and diabetes education | Other | Telemedicine Diabetes Intervention |
Primary outcome
Change in HbA1c % from baseline
Time frame: 3 and 6 month
1 secondary outcome
Patient satisfaction
Time frame: 6 month
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 28 May 2015.
- Derived from this study: PubMed 25061149Toledo FG, Ruppert K, Huber KA, Siminerio LM. Efficacy of the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model for diabetes care. Diabetes Care. 2014 Aug;37(8):e179-80. doi: 10.2337/dc13-1909. No abstract available.
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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.
Frederico Toledo, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine diabetes intervention in people with Type 2 Diabetes, run by University of Pittsburgh 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 3 inclusion and 2 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 28 May 2015. 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 HbA1c % from baseline (time frame: 3 and 6 month). 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 NCT01339208, 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 28 May 2015.