Diabetes Mellitus, Type 2NCT06370494
Testing New Models of Diabetes Self-Management to Improve Population Health
A study testing Living Healthier with Diabetes in people with Diabetes Mellitus, Type 2, run by Texas A&M University at 1 site in United States.
Trial summary
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas. Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Living Healthier with Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 31 Mar 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
- HbA1c value greater than or equal to 7.5%
- Adults ages 25 years and older
- All genders
- Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
- Ability to read and speak English
- Resides in Texas
Who cannot join
- Pregnant women
- Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
- Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
- Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
- Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
Trial locations and contacts
1 site in 1 country.
About this study
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.
Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
Read the detailed description
A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Living Healthier with 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.
Living Healthier with DiabetesBehavioural
Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Making Moves with Diabetes [MMWD] Group | Experimental | Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups. Receives: Behavioral: Living Healthier with Diabetes |
| App Group | Experimental | Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups. Receives: Behavioral: Living Healthier with Diabetes |
| Combo Group | Experimental | A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups. Receives: Behavioral: Living Healthier with Diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.
Measured: 12 months
Secondary outcomes (5)
Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).
Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version). 10 True False questions will be included with answers of True, False, and I don't know. Correct responses receive 1 point indicating a range of 0-10 points for this outcome measure.
Measured: 12 months
Diabetes Self Care
Diabetes self-management behavior will be measured by the adapted Summary of Diabetes Self-Care Activities Measure (SDSCA). The SDSCA is a brief self-report questionnaire that includes items assessing the following aspects of the diabetes regimen: general diet, specific exercise, blood-glucose testing, foot care, alcohol, and smoking. The scale has been adapted to examine self-care activities before and since COVID-19. Furthermore, a question about alcohol drinking has been added. Diabetes Self-care is the number of days a participant performed certain activities pertaining to diabetes care in a typical week. The diabetes self care scale is 8 questions asking how many days per week a participant engaged in a behavior on a scale of 0-7 days. Therefore, the scale ranged from 0-56 points, with higher points indicating greater occurrence of diabetes self care.
Measured: 12 months
Diabetes Care Confidence
Confidence in doing specific activities related to diabetes will be measured by the Self-Efficacy for Diabetes Scale. The scale is a self-report instrument that asks how confident individuals feel doing specific activities related to diabetes (e.g., diet, exercise, blood sugar monitoring).Diabetes confidence is how confident a participant is in their own ability to perform certain activities. To analyze this, a sum of 8 questions was taken. Diabetes confidence scale is 8 questions on scale of 1-10 ranging from ("not at all confident" to "totally confident"). The higher the sum is, the higher the confidence. Therefore, final outcome scores will range from 8-80, with higher scores indicating greater confidence in diabetes management.
Measured: 12 months
Diabetes care distress
Distress related to living with diabetes will be measured by the 2-item Diabetes Distress Screening Scale (DDS2). The DDS2 asks participants to rate the degree to which of perceived magnitudes of problems concerning diabetes that may have distressed or bothered participants. Diabetes distress is how distress a participant is in performing activities pertaining to diabetes care. Diabetes distress scale is 6 questions on a scale of 1-6 ranging from ("not a problem" to "a very serious problem"). To analyze this, a sum of 6 questions was taken. The higher the sum is, the more distressed the participant is. Therefore, the scale ranged from 6-36 points, with higher points more diabetes distress.
Measured: 12 months
A1C
-Number of participants with A1c reduction that is at least .5 (clinically significant). In addition to the continuous A1C measurements, an indicator variable will be created to indicate a clinically meaningful change (e.g., whether A1C dropped more than 0.5 at the 6-month). Possible A1c values ranging from 4 to 14 due to instrument precision at the higher values.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Feb 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Responsible party
- Principal investigator, Marcia G Ory, Texas A&M University
- Investigators
- Marcia Ory, Principal investigator, Texas A&M Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370494
- Sponsor's protocol ID
- IRB2020-0956D
- Status last verified
- Apr 2024
- First submitted
- 8 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing New Models of Diabetes Self-Management to Improve Population Health
- ClinicalTrials.gov ID
- NCT06370494
- Acronym / sponsor ID
- IRB2020-0956D
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Blue Cross Blue Shield
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Apr 2024 (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.
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.
Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
Detailed description
A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
| Arm | Type | Receives |
|---|---|---|
| Virtual Making Moves with Diabetes [MMWD] Group | Experimental | Behavioral: Living Healthier with DiabetesVirtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups. |
| App Group | Experimental | Behavioral: Living Healthier with DiabetesSmartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups. |
| Combo Group | Experimental | Behavioral: Living Healthier with DiabetesA combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
- HbA1c value greater than or equal to 7.5%
- Adults ages 25 years and older
- All genders
- Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
Key exclusion criteria (5 listed)
- Pregnant women
- Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
- Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
- Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
- Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
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 |
|---|---|---|
| Living Healthier with DiabetesInterventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys. | Behavioural | App Group, Combo Group, Virtual Making Moves with Diabetes [MMWD] Group |
Primary outcome
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
Time frame: 12 months
A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.
5 secondary outcomes
Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).
Time frame: 12 months
Diabetes Self Care
Time frame: 12 months
Diabetes Care Confidence
Time frame: 12 months
Diabetes care distress
Time frame: 12 months
A1C
Time frame: 12 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 17 Apr 2024.
- 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.
Marcia Ory principal investigator
Texas A&M Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Healthier with Diabetes in people with Diabetes Mellitus, Type 2, run by Texas A&M 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 7 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 17 Apr 2024. 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?
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome. (time frame: 12 months). 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 17 Apr 2024.