Diabetes Mellitus, Type 2 Clinical Trial
Official title:
diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)
This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED
randomized control trial. The study is being conducted by the Minneapolis Heart Institute
Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical
Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).
The study will examine the impact of a registered dietitian-led, primary care integrated,
telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual
care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c
<8%, not using tobacco and taking an aspirin as appropriate.
Individuals will be invited to attend a baseline visit where they will have lab work done,
anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment.
They will formally consent to participation by signing a study consent form. The same
measures will be collected after completion of the one year study.
Study participants will receive two sessions of free lab work, a diabetes education book, and
brief coaching with a registered dietitian/certified diabetes educator. In addition, those
randomized to the phone coaching will have access to a registered dietitian/certified
diabetes educator on a monthly basis for one year of personalized health coaching for free.
The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting
all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin
use).
This program is designed to complement usual clinic-based primary care, with coaches
documenting lab, biometrics and medication adjustments in the EHR, along with documenting
phone encounters and communicating directly with patients' PCPs as needed. Documentation in
the EHR uses an order created specifically for the study indicating the patient's research
status.
Lab work required as part of this research study at baseline and 12 months is covered by the
study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month
study visits are the responsibility of the patient and/or their insurance
;
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