An interventional study of Multicomponent Implementation Strategy (MCIS) Bundle and Standard of Care in Type Two Diabetes Mellitus, sponsored by Mary Lacy. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Mary Lacy · Not applicable, Interventional, and Health services research
Among 3,021 studies in Diabetes Mellitus with a site in United States — 288 open to participants now, 389 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,021 studies in Diabetes Mellitus with a site in United States, this one is the 1,157th largest by planned enrollment of the 2,500 interventional ones that give a count, is the only one that started in 2029, is one of 1,416 with no phase, reaches primary completion later than 359 of the 381 other live ones, and was the 3,018th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 96 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →288 of the 3,021 studies in Diabetes Mellitus with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · healthy volunteers too.
The full table on the hub →3,021 studies; the count open now beside each. This study's row is marked.
First in 1976; this study’s year is marked. 1 started in 2029.
Median enrollment 82 across the 2,500 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 987 (41%) have results posted.
852 of 3,021 have an industry lead sponsor. The 10 most frequent:
Mary Lacy is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Mary Lacy has 3 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Among the 3,021 studies in Diabetes Mellitus with a site in United States, from their registry updates:
A multicomponent implementation strategy bundle designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics. The initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities.
This is a hybrid type 3 effectiveness-implementation trial involving primary care clinics among four healthcare systems in Kentucky. Cluster randomization of clinics (and the patients therein) will be stratified by healthcare system such that 2 clinics will be randomized to the intervention arm, and 2 clinics will be assigned to the control arm; across 4 health care systems, this will result in 8 clinics per study arm for a total of 16 clinics. Clinics randomized to intervention will implement an optimized multicomponent implementation strategy (MCIS) bundle (8 clinics) or standard of care (8 clinics) and implementation outcomes will be evaluated. The MCIS bundle is designed to improve Diabetes Self-Management Education and Support (DSMES) referral and utilization in rural primary care clinics in Kentucky and the initial bundle includes: (1) establishing electronic health record (EHR) referral systems, (2) creating patient face sheets for providers, (3) discussing DSMES referrals during clinician and staff implementation team meetings, and (4) developing DSMES-specific marketing materials and promotional activities. Primary implementation outcome is reach, as defined by proportion of eligible patients referred to DSMES. Secondary outcomes include provider-level adoption of learning collaborative activities, effectiveness (i.e., patient A1c, DSMES attendance), implementation (i.e., fidelity; perceived feasibility, acceptability, and appropriateness of implementation strategies; patient facilitators and barriers to DSMES attendance), and maintenance at 12-month follow-up. Following the trial, the cost-effectiveness of the optimized MCIS bundle will be determined.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Rural primary care clinics randomized to the intervention group will receive the multicomponent implementation (MCIS) bundle designed to improve referral to and utilization of diabetes self-management education and support (DSMES).
Behavioral: Multicomponent Implementation Strategy (MCIS) Bundle
Rural primary care clinics randomized to the control group will continue standard of care without the implementation of the MCIS bundle.
Other: Standard of Care
A multicomponent implementation strategy designed to improve DSMES referral and utilization in rural primary care clinics. Strategies include establishing EHR referral systems, creating patient face sheets for providers, discussing DSMES referrals during clinician and staff implementation team meetings, and developing DSMES-specific marketing materials and promotional activities.
Clinics randomized to standard-of-care group will continue their usual clinical practices without implementation of the multicomponent implementation strategy (MCIS) bundle.
Percentage of Eligible Patients Referred to DSMES
Percentage of eligible patients with diabetes who receive a referral to diabetes self-management education and support (DSMES).
Time frame: 9 Months After Initiation of Intervention
Change in Mean HbA1c for Patients with HbA1c >9%
HbA1c control will be extracted from the electronic health record and assessed as change in mean HbA1c from baseline to the end of the intervention and at 1-month and 12-month follow-up, and change in the percentage of patients with HbA1c greater than 9%.
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Percentage of Providers Referring Patients to DSMES
Percentage of providers referring patients to DSMES, calculated as the number of providers referring patients to DSMES divided by the total number of providers at the clinic.
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Change in DSMES Referral Rate During the 12-Month Sustainment Period
Maintenance will be measured as the change in DSMES referral rate over the 12-month assessment period.
Time frame: Monthly during the 12-month sustainment period
Percentage of Patients Completing DSMES
DSMES attendance will be extracted and reported by participating clinics. Attendance will be considered complete when a patient has attended 2 or more hours of DSMES, in alignment with state reporting.
Time frame: Baseline and monthly during active intervention through 12 month follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Apr 2029; primary completion for Dec 2030, 20 months later.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 20 months is below that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Mary Lacy