Diabetes Mellitus, Type 2DD-TXTNCT04227379
Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
A study testing Intervention 1- DSMS+ and Comparison - DSMS in people with Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Intervention 1- DSMS+ and Comparison - DSMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jan 2023to 30 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans
- Active VHA patients with type 2 diabetes
- Had at least 4 VA outpatient encounters in the previous year
- Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in texting intervention development
- Have HbA1c lab data (2+ values) in the 12 months prior to RCT recruitment.
- Have inadequate glycemic control for at least 50% of the 6 months before invitation to participate
Who cannot join
- Non-Veterans
- Not having access to their own or a cohabiting family member's cell phone or smartphone for participation
- Not willing and able to text
- A visual impairment that would prevent them from reading or replying to text messages
- Cognitively incapable of consent to participate (Failure of Short Blessed Test)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
About this study
One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.
Read the detailed description
Type 2 Diabetes is a common, complex health condition which can result in many serious and costly health complications if not treated and controlled properly. One in four Veterans are diagnosed with Type 2 Diabetes. Vulnerable Veterans, such as minority, low-income, or rural Veterans, and Veterans with comorbid mental health diagnoses, are disproportionately affected and are less likely to have their diabetes under control. The goal of this study, using a randomized comparative effectiveness design, was to test the comparative effectiveness of an interactive, customizable diabetes self-management support texting protocol (DSMS+), versus a standardized education-only intervention (DSMS) in a sample of Veterans with uncontrolled diabetes.
The team will invited Veterans age 18 years and above who were actively receiving care at the study sites (as determined by upcoming scheduled appointment) who had uncontrolled glucose (HbA1c >= 8.0% for at least 50% of the most recent 6 months). Participants who met these conditions and enrolled in the study were randomized to one of two study arms: DSMS or DSMS+. Both arms received text-based diabetes self-management support for 6 months. The primary outcome was HbA1c percent time in control. Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R), diabetes self-efficacy, diabetes distress, LDL, and blood pressure control. The team hypothesized that the customizable texting intervention (DSMS+) would result in better proximal health outcomes and diabetes self-management behaviors vs a standardized, education-only protocol (DSMS).
Please note that we previously referred to DSMS as DSE (diabetes standardized education) and DSMS+ as DD-TXT (Diabetes Disparities: Texting to Extend Treatment) after the trial name. We updated the names to better clarify that both are diabetes self-management support texting interventions, with DSMS+ having additional, customizable and interactive content that patients can choose from.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Intervention 1- DSMS+, Comparison - DSMS
- Keywords
- text messaging, Health Equity, Health Care Quality, Access, and Evaluation, self-management
- 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.
Intervention 1- DSMS+Behavioural
Also called DD-TXT
Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging th
Comparison - DSMSBehavioural
Also called DSE
Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful.
| Study group | Role | What they receive |
|---|---|---|
| DSMS+ (DSMS Plus) | Experimental | Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging that supported their diabetes self-management goals. Patients could customize the timing and frequency of their messages. DSMS+ participants also received a once monthly message asking whether the messages had been helpful. Receives: Behavioral: Intervention 1- DSMS+ |
| DSMS | Active comparator | Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful. Receives: Behavioral: Comparison - DSMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c Percent Time in Control
The investigators examined the changes in HbA1c percent time in control. The cutoff for being in control was a HbA1c of 8.0 percent. Using HbA1c measures pulled from the electronic medical record data, we estimated the percentage of time HbA1c<8.0% in the 6 month window prior to enrollment and during the 6 month trial. We then calculated the change in HbA1c percent time in control for each participant.
Measured: pre-enrollment, 6 month follow up
Change in HbA1c
We examined the changes in HbA1c. These data were calculated using HbA1c measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the closest HbA1c value before enrollment. The 6-month follow-up HbA1c was measured by the closest A1c to day 180 (6-months post-enrollment) available within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.
Measured: pre-enrollment, 6 month follow-up
Secondary outcomes (13)
Change in LDL
We examined the changes in LDL. These data were calculated using LDL measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the mean LDL value in the 6 months prior to enrollment. The 6-month follow-up LDL was measured by the mean of any LDL values available within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.
Measured: pre-enrollment, 6 month follow up
Change in Systolic Blood Pressure
We examined the changes in systolic blood pressure (SBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment SBP was measured by the mean SBP in the year (365 days) prior to enrollment. The 6-month follow-up SBP was measured by the mean SBP taken within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.
Measured: pre-enrollment, 6 month follow up
Change in Diastolic Blood Pressure
We examined the changes in diastolic blood pressure (DBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment DBP was measured by the mean DBP in the year (365 days) prior to enrollment. The 6-month follow-up DBP was measured by the mean DBP taken within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.
Measured: pre-enrollment, 6 months
Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)
Secondary outcomes included self-reported adherence to diabetes self-care recommendations (SCI-R). We administered the SCI-R to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by averaging the 12 items relevant to type 2 diabetes, each item scored 1(Never) to 5(Always), and converting to a 0-100 scale. A higher score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported Diabetes Self-efficacy Scale (DSES)
We measured diabetes self-efficacy using the Diabetes Self-Efficacy Scale (DSES). We administered the DSES to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the average of 8 items, each item 1(Not at all Confident) to 10(Totally Confident), with a theoretical scale of 1 to 10, and a higher score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported Diabetes Distress Scale (DDS17)
Secondary outcomes included self-reported diabetes distress measured by the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 17 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the change between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported DDS17 Emotional Burden Subscale
The DDS17 Emotional Burden Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported DDS17 Physician-related Distress Subscale
The DDS17 Physician-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 4 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported DDS17 Regimen-Related Distress Subscale
The DDS17 Regimen-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported DDS17 Interpersonal Distress Subscale
The DDS17 Interpersonal Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 3 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
We measured self-reported adherence to diabetes medications using the ARMS-D. We administered the ARMS-D to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the sum of 11 items, each item 1(None of the time) to 4(All of the time), with a theoretical score range of 11 to 44, and a lower score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported Physical Health Summary Score
Secondary outcomes included self-reported physical health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey (VR-12) into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Change in Self-reported Mental Health Summary Score
Secondary outcomes included self-reported mental health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start30 Jan 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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 (4)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 VA Office of Research and DevelopmentThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who consented to participate were asked to complete the baseline survey instruments. Participants were then randomized to a study arm, using a separate randomization table per site. Since women are underrepresented among VHA patients, the study staff recruited women first to oversample them, with the goal of 10-20% women at each site. The goal was to recruit 400 participants (200 per site). Participants in both arms were asked to complete a follow-up survey and interview after completing the 6-month texting intervention they were assigned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Stephanie L Shimada, PhD, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227379
- Sponsor's protocol ID
- IIR 17-087
- Acronym
- DD-TXT
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2020
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
PubMed 15920050Ritter PL, Lorig K, Laurent DD. Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales. Diabetes Educ. 2016 Apr;42(2):167-77. doi: 10.1177/0145721716628648. Epub 2016 Feb 4.
PubMed 26846336Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
PubMed 18474888Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
PubMed 24209600
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
- ClinicalTrials.gov ID
- NCT04227379
- Acronym / sponsor ID
- DD-TXT / IIR 17-087
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- text messaging, Health Equity, Health Care Quality, Access, and Evaluation, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.
Detailed description
Type 2 Diabetes is a common, complex health condition which can result in many serious and costly health complications if not treated and controlled properly. One in four Veterans are diagnosed with Type 2 Diabetes. Vulnerable Veterans, such as minority, low-income, or rural Veterans, and Veterans with comorbid mental health diagnoses, are disproportionately affected and are less likely to have their diabetes under control. The goal of this study, using a randomized comparative effectiveness design, was to test the comparative effectiveness of an interactive, customizable diabetes self-management support texting protocol (DSMS+), versus a standardized education-only intervention (DSMS) in a sample of Veterans with uncontrolled diabetes.
The team will invited Veterans age 18 years and above who were actively receiving care at the study sites (as determined by upcoming scheduled appointment) who had uncontrolled glucose (HbA1c >= 8.0% for at least 50% of the most recent 6 months). Participants who met these conditions and enrolled in the study were randomized to one of two study arms: DSMS or DSMS+. Both arms received text-based diabetes self-management support for 6 months. The primary outcome was HbA1c percent time in control. Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R), diabetes self-efficacy, diabetes distress, LDL, and blood pressure control. The team hypothesized that the customizable texting intervention (DSMS+) would result in better proximal health outcomes and diabetes self-management behaviors vs a standardized, education-only protocol (DSMS).
Please note that we previously referred to DSMS as DSE (diabetes standardized education) and DSMS+ as DD-TXT (Diabetes Disparities: Texting to Extend Treatment) after the trial name. We updated the names to better clarify that both are diabetes self-management support texting interventions, with DSMS+ having additional, customizable and interactive content that patients can choose from.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients who consented to participate were asked to complete the baseline survey instruments. Participants were then randomized to a study arm, using a separate randomization table per site. Since women are underrepresented among VHA patients, the study staff recruited women first to oversample them, with the goal of 10-20% women at each site. The goal was to recruit 400 participants (200 per site). Participants in both arms were asked to complete a follow-up survey and interview after completing the 6-month texting intervention they were assigned.
| Arm | Type | Receives |
|---|---|---|
| DSMS+ (DSMS Plus) | Experimental | Behavioral: Intervention 1- DSMS+Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging that supported their diabetes self-management goals. Patients could customize the timing and frequency of their messages. DSMS+ participants also received a once monthly message asking whether the messages had been helpful. |
| DSMS | Active comparator | Behavioral: Comparison - DSMSParticipants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veterans
- Active VHA patients with type 2 diabetes
- Had at least 4 VA outpatient encounters in the previous year
- Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in texting intervention development
- Have HbA1c lab data (2+ values) in the 12 months prior to RCT recruitment.
Key exclusion criteria (5 listed)
- Non-Veterans
- Not having access to their own or a cohabiting family member's cell phone or smartphone for participation
- Not willing and able to text
- A visual impairment that would prevent them from reading or replying to text messages
- Cognitively incapable of consent to participate (Failure of Short Blessed Test)
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 |
|---|---|---|
| Intervention 1- DSMS+Also: DD-TXTParticipants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging th | Behavioural | DSMS+ (DSMS Plus) |
| Comparison - DSMSAlso: DSEParticipants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful. | Behavioural | DSMS |
Primary outcome
Change in HbA1c Percent Time in Control
Time frame: pre-enrollment, 6 month follow up
The investigators examined the changes in HbA1c percent time in control. The cutoff for being in control was a HbA1c of 8.0 percent. Using HbA1c measures pulled from the electronic medical record data, we estimated the percentage of time HbA1c<8.0% in the 6 month window prior to enrollment and during the 6 month trial. We then calculated the change in HbA1c percent time in control for each participant.
Change in HbA1c
Time frame: pre-enrollment, 6 month follow-up
We examined the changes in HbA1c. These data were calculated using HbA1c measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the closest HbA1c value before enrollment. The 6-month follow-up HbA1c was measured by the closest A1c to day 180 (6-months post-enrollment) available within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.
13 secondary outcomes
Change in LDL
Time frame: pre-enrollment, 6 month follow up
Change in Systolic Blood Pressure
Time frame: pre-enrollment, 6 month follow up
Change in Diastolic Blood Pressure
Time frame: pre-enrollment, 6 months
Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)
Time frame: Baseline, 6 months
Change in Self-reported Diabetes Self-efficacy Scale (DSES)
Time frame: Baseline, 6 months
Change in Self-reported Diabetes Distress Scale (DDS17)
Time frame: Baseline, 6 months
Change in Self-reported DDS17 Emotional Burden Subscale
Time frame: Baseline, 6 months
Change in Self-reported DDS17 Physician-related Distress Subscale
Time frame: Baseline, 6 months
Change in Self-reported DDS17 Regimen-Related Distress Subscale
Time frame: Baseline, 6 months
Change in Self-reported DDS17 Interpersonal Distress Subscale
Time frame: Baseline, 6 months
Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
Time frame: Baseline, 6 months
Change in Self-reported Physical Health Summary Score
Time frame: Baseline, 6 months
Change in Self-reported Mental Health Summary Score
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15920050Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
- Background: PubMed 26846336Ritter PL, Lorig K, Laurent DD. Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales. Diabetes Educ. 2016 Apr;42(2):167-77. doi: 10.1177/0145721716628648. Epub 2016 Feb 4.
- Background: PubMed 18474888Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Background: PubMed 24209600Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.
- 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.
Stephanie L Shimada, PhD principal investigator
VA Bedford HealthCare System, Bedford, MA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1- DSMS+ and Comparison - DSMS in people with Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 3 sites 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 1 Jun 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?
Change in HbA1c Percent Time in Control (time frame: pre-enrollment, 6 month follow up). The study lists 2 primary outcomes in all. 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 NCT04227379, which also lists 4 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 26 Jun 2026.