Diabetes Mellitus, Type 2TIDESNCT02088658
Technology Intensified Diabetes Education Study in African Americans
A study testing Technology Intensified in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Adult-Onset, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- Technology Intensified
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
- Self-identified as AA
- Subject must be willing to use the FORA monitoring system for 12 months
- Subjects must be able to communicate in English
- Subjects must have access to a telephone (landline for data uploads) for the study period
Who cannot join
- Mental confusion on interview suggesting significant dementia
- Participation in other diabetes clinical trials
- Alcohol or drug abuse/dependency
- Active psychosis or acute mental disorder
- Life expectancy <12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes
The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.
Read the detailed description
African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM.
This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II
- Being tested
- Technology Intensified
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II, African Americans, Blacks, non-Hispanic Blacks, Randomized Control Trial, Controlled Clinical Trial, Behavioral Research, Behavioral Medicine
- 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.
Technology IntensifiedBehavioural
The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Techonology Intensified | Experimental | Subjects randomized to this group will receive: 1) the FORA system for self-monitoring; 2) weekly telephone-delivered diabetes education/skills training; 3) patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions); and 4) patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools). The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes. Receives: Behavioral: Technology Intensified |
| Usual Care | No intervention | Apart from study visits, patients will be followed by their primary care providers. The provider will be responsible for determining treatment parameters, making changes in the treatment regimen, and determining the timing of follow up visits. Between scheduled office encounters, contact between patient and provider will be patient initiated. The provider may use clinic nurses to follow up on problematic patients or patients with abnormal results. In essence, this group will receive the current standard of care at the study clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Hemoglobin A1c (HbA1c): blood specimens collected at the 12-months follow-up visit
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2021
- Study completionJan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Leonard Ehianu Egede, State University of New York at Buffalo
- Investigators
- Leonard E Egede, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088658
- Sponsor's protocol ID
- Pro00015064
- Other IDs
- 1R01DK098529
- Acronym
- TIDES
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2014
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Williams JS, Lynch CP, Knapp RG, Egede LE. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2014 Nov 25;15:460. doi: 10.1186/1745-6215-15-460.
PubMed 25425504Egede LE, Campbell JA, Walker RJ. Development and Psychometric Properties of the 5-Item Diabetes Fatalism Scale Short Form (DFS-SF). J Gen Intern Med. 2026 Feb 25:10.1007/s11606-026-10287-9. doi: 10.1007/s11606-026-10287-9. Online ahead of print.
PubMed 41741866
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02088658
- Acronym / sponsor ID
- TIDES / Pro00015064
- Conditions
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Adult-Onset, Diabetes Mellitus, Non-Insulin-Dependent, Diabetes Mellitus, Noninsulin Dependent, Diabetes Mellitus, Type II, African Americans, Blacks, non-Hispanic Blacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jan 2026 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Posted 6 Mar 2026
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 test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.
Detailed description
African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (HbA1c) is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple randomized clinical trials (RCTs) show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM.
This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Techonology Intensified | Experimental | Behavioral: Technology IntensifiedSubjects randomized to this group will receive: 1) the FORA system for self-monitoring; 2) weekly telephone-delivered diabetes education/skills training; 3) patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions); and 4) patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools). The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes. |
| Usual Care | No intervention | –Apart from study visits, patients will be followed by their primary care providers. The provider will be responsible for determining treatment parameters, making changes in the treatment regimen, and determining the timing of follow up visits. Between scheduled office encounters, contact between patient and provider will be patient initiated. The provider may use clinic nurses to follow up on problematic patients or patients with abnormal results. In essence, this group will receive the current standard of care at the study clinics. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥21 years
- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
- Self-identified as AA
- Subject must be willing to use the FORA monitoring system for 12 months
- Subjects must be able to communicate in English
Key exclusion criteria (5 listed)
- Mental confusion on interview suggesting significant dementia
- Participation in other diabetes clinical trials
- Alcohol or drug abuse/dependency
- Active psychosis or acute mental disorder
- Life expectancy <12 months
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 |
|---|---|---|
| Technology IntensifiedThe intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions. | Behavioural | Techonology Intensified |
Primary outcome
Hemoglobin A1c
Time frame: 12 months post randomization
Hemoglobin A1c (HbA1c): blood specimens collected at the 12-months follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25425504Williams JS, Lynch CP, Knapp RG, Egede LE. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2014 Nov 25;15:460. doi: 10.1186/1745-6215-15-460.
- Derived from this study: PubMed 41741866Egede LE, Campbell JA, Walker RJ. Development and Psychometric Properties of the 5-Item Diabetes Fatalism Scale Short Form (DFS-SF). J Gen Intern Med. 2026 Feb 25:10.1007/s11606-026-10287-9. doi: 10.1007/s11606-026-10287-9. Online ahead of print.
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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.
Leonard E Egede, MD, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Intensified in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Adult-Onset, run by State University of New York at Buffalo 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 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 6 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 12 months post randomization). 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 NCT02088658, which also lists 2 linked publications.
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 Mar 2026.