Diabetes MellitusNCT00629434
A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
A study testing diabetes education via telemedicine and diabetes education in-person in people with Diabetes Mellitus, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
This study compares group diabetes education in-person versus via telemedicine Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- diabetes education via telemedicine and diabetes education in-person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Aug 2008
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or type 2 diabetes mellitus
- age > 18 years
Who cannot join
- Profound vision loss
- Severe hearing impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Joslin Diabetes Center Affiliate at SUNY Upstate Medical University
Syracuse, New York, 13214
About this study
This study compares group diabetes education in-person versus via telemedicine
Read the detailed description
Diabetes education is important in the treatment of the person with diabetes. A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness. Unfortunately, comprehensive diabetes care is not available to all persons with diabetes. One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center. many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards. We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes. We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas. Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center. The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.
- Conditions
- Diabetes Mellitus
- Being tested
- diabetes education via telemedicine, diabetes education in-person
- Keywords
- Diabetes Education, Telemedicine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes education via telemedicineOther
This arm will receive diabetes group education via telemedicine
diabetes education in-personOther
In this arm the group of patients with diabetes will receive diabetes education in-person
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm will receive diabetes education via telemedicine Receives: Other: diabetes education via telemedicine |
| 2 | Active comparator | diabetes education in-person Receives: Other: diabetes education in-person |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Measured: baseline, 3 mo post intervention, 6 mo post intervention
Secondary outcomes (2)
PAID scale
Measured: baseline, 3 and 6 months post intervention
Diabetes Treatment Satisfaction Questionnaire
Measured: Baseline, 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startJun 2001
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629434
- Sponsor's protocol ID
- UMU IRB # 4510F
- Other IDs
- UMU IRB # 4510F
- Status last verified
- Oct 2021
- First submitted
- 25 Feb 2008
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
- ClinicalTrials.gov ID
- NCT00629434
- Acronym / sponsor ID
- UMU IRB # 4510F
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Education, Telemedicine
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 68 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Mar 2008 (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.
This study compares group diabetes education in-person versus via telemedicine
Detailed description
Diabetes education is important in the treatment of the person with diabetes. A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness. Unfortunately, comprehensive diabetes care is not available to all persons with diabetes. One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center. many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards. We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes. We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas. Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center. The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: diabetes education via telemedicineThis arm will receive diabetes education via telemedicine |
| 2 | Active comparator | Other: diabetes education in-persondiabetes education in-person |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 or type 2 diabetes mellitus
- age > 18 years
Key exclusion criteria (2 listed)
- Profound vision loss
- Severe hearing impairment
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 |
|---|---|---|
| diabetes education via telemedicineThis arm will receive diabetes group education via telemedicine | Other | 1 |
| diabetes education in-personIn this arm the group of patients with diabetes will receive diabetes education in-person | Other | 2 |
Primary outcome
A1c
Time frame: baseline, 3 mo post intervention, 6 mo post intervention
2 secondary outcomes
PAID scale
Time frame: baseline, 3 and 6 months post intervention
Diabetes Treatment Satisfaction Questionnaire
Time frame: Baseline, 3 and 6 months post intervention
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
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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 diabetes education via telemedicine and diabetes education in-person in people with Diabetes Mellitus, run by State University of New York - Upstate Medical University 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 2 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: stopped early, as of the sponsor's last update on 6 Oct 2021. 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 was stopped early. Results are not available in the source record.
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?
A1c (time frame: baseline, 3 mo post intervention, 6 mo post intervention). 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 6 Oct 2021.