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N/A N=21,664 Randomized Single-blind Treatment

Pre-Diabetes Cardiovascular (CV) Care (Pre-Diabetes Wizard)

Pre-diabetes

Enrolled (actual)
21,664
Serious AEs
17.5%
Results posted
Mar 2021
Primary outcome: Primary: Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke — 1.100; 1.096 units on a scale — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Clinical Decision Support (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
HealthPartners Institute
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
1.100; 1.096 <0.05 sig

Summary

Nearly one in three adults has prediabetes, a condition that substantially increases the risk of heart attacks and stroke. The increased cardiovascular risk associated with prediabetes can be effectively managed by lifestyle changes or medication therapy, but recent data shows few prediabetes patients are treated effectively. In this project, we will adapt, implement, and evaluate a proven electronic health record-linked, web-based clinical decision support system to identify patients with prediabetes and provide prioritized treatment recommendations to patients and providers in a rural health system. The results of the project will provide a template for implementation of more efficient and effective rural healthcare and have the potential to substantially and improve cardiovascular quality of care and clinical outcomes of millions of rural Americans with prediabetes.

Eligibility Criteria

Inclusion Criteria

  • Pre-Diabetes Diagnosis or Clinical Lab Values and
  • One or more of the following CV risk factors: Current smoking, Hypertension, elevated LDL, or BMI not within normal range, AND
  • at least one subsequent primary care visit to a randomized clinic 12 to 24 months after the index visit.

Exclusion Criteria

  • Evidence of Diabetes in the previous 12 months
  • Pregnant
  • Hospice care or Chemotherapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02759055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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