Trial Outcomes & Findings for Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care (NCT NCT05265312)

NCT ID: NCT05265312

Last Updated: 2025-02-05

Results Overview

Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1910 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-02-05

Participant Flow

Participant milestones

Measure	Intervention Clinic Patients with prediabetes seen for routine care at intervention clinic START diabetes prevention clinical pathway: The diabetes prevention clinical pathway will focus on the following steps: 1. Screen/test - testing of eligible patients for prediabetes/diabetes 2. Education - Primary Care Physicians (PCPs) will be encouraged to take an online learning module and in-person group training on prediabetes management and patients with prediabetes will receive a handout about prediabetes prior to their upcoming PCP visit 3. Action - PCPs will use a shared decision-making guide and treatment algorithm to discuss options with patients at their visit 4. Referral - patients may be referred to Diabetes Prevention Program (DPP) and/or medical nutrition therapy (MNT) 5. Treat - patients will be scheduled for a follow-up visit within 3-9 months with their PCP or care team to continue addressing prediabetes.	Control Clinic Patients with prediabetes seen for routine care at control clinic
Overall Study STARTED	873	1037
Overall Study COMPLETED	873	1037
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implementation and Evaluation of a Diabetes Prevention Clinical Pathway in Primary Care

Baseline characteristics by cohort

Measure	Intervention Clinic n=873 Participants START diabetes prevention clinical pathway	Control Clinic n=1037 Participants Routine usual care	Total n=1910 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 13.6 • n=5 Participants	60.7 years STANDARD_DEVIATION 14.6 • n=7 Participants	61.6 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex/Gender, Customized Female	545 Participants n=5 Participants	617 Participants n=7 Participants	1162 Participants n=5 Participants
Sex/Gender, Customized Male	327 Participants n=5 Participants	420 Participants n=7 Participants	747 Participants n=5 Participants
Sex/Gender, Customized Non-binary	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	26 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	825 Participants n=5 Participants	977 Participants n=7 Participants	1802 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	34 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized Asian	62 Participants n=5 Participants	93 Participants n=7 Participants	155 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	220 Participants n=5 Participants	280 Participants n=7 Participants	500 Participants n=5 Participants
Race/Ethnicity, Customized Other	33 Participants n=5 Participants	49 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized Unknown/Declined to Answer	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized White	544 Participants n=5 Participants	604 Participants n=7 Participants	1148 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of PCP visits where ppt referred to Diabetes Prevention Program during intervention period

Outcome measures

Measure	Intervention Clinic n=1754 pcp visits START diabetes prevention clinical pathway	Control Clinic n=2328 pcp visits Routine usual care
Number of PCP Visits Where Ppt Was Referred to Diabetes Prevention Program Within 30 Days of Visit	47 pcp visits	10 pcp visits

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Intervention Clinic n=1754 pcp visits START diabetes prevention clinical pathway	Control Clinic n=2328 pcp visits Routine usual care
Number of PCP Visits Where Ppt Was Prescribed Metformin Within 30 Days	58 pcp visits	39 pcp visits

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Intervention Clinic n=1754 pcp visits START diabetes prevention clinical pathway	Control Clinic n=2328 pcp visits Routine usual care
Number of PCP Visits Where Ppt Was Referred to Medical Nutrition Therapy Within 30 Days	3 pcp visits	37 pcp visits

SECONDARY outcome

Timeframe: 12 months

Fasting glucose or Hemoglobin A1c

Outcome measures

Measure	Intervention Clinic n=873 Participants START diabetes prevention clinical pathway	Control Clinic n=1037 Participants Routine usual care
Number of Participants Who Complete Glycemic Lab Testing Out of Those With an Order During Intervention Period	800 Participants	906 Participants

SECONDARY outcome

Timeframe: Baseline and 12 months

Proportion achieving 5% or greater weight reduction

Outcome measures

Measure	Intervention Clinic n=873 Participants START diabetes prevention clinical pathway	Control Clinic n=1037 Participants Routine usual care
Achieve 5% or Greater Reduction in Weight Compared to Baseline	49 Participants	43 Participants

Adverse Events

Intervention Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eva Tseng

Johns Hopkins University School of Medicine

Phone: 410-583-2774

Email: etseng3@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place