A. Study Design
· The study design is a randomized clinical trial in which investigators or sites will be randomized to provide either intervention (in the form of personalized diabetes education) or usual care to study participants.
B. Major Eligibility Criteria
· Age >=18 years
· Type 1 or type 2 diabetes
· Patient is not eligible if patient has a known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
C. Treatment Groups
Study participants will be assigned to either the intervention or the control group
1. Intervention Group
The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks):
- Measurement of HbA1c in office with immediate feedback
- Measurement of blood pressure with immediate feedback
- Assessment of retinopathy risk with immediate feedback
- Personalized risk assessment reports based on current HbA1c
- Brief assessment of patient understanding of key issues with immediate feedback
- Supplemental diabetes management educational materials (provided at baseline only)
- Feedback to primary care provider
- Email reminder to study participants with email access of individualized risk assessment findings
2. Control (Usual care)
D. Treatment Group Allocation
Investigators or sites will be randomized to provide either intervention or usual care to study participants. A study participant will be assigned to either the control or intervention group according to which treatment group the enrolling investigator is randomized.
E. Sample Size
At least 2000 study participants with a baseline central laboratory measured HbA1c ≥ 6.0% from approximately 40 sites, each recruiting 50 study participants.
F. Duration of Follow-up
Duration of follow-up is 24 months with primary outcome at 12 months.
G. Follow-up Visit Schedule Outcomes
- All study participants will have follow-up visits at 12 months and 24 months at which time outcome assessments will be made.
- Additional visits will be conducted as needed for the study participant's eye condition.
H. Primary Outcome Measures
1. Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months.
2. Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care every 12 months.