Project Summary/Abstract
Type 2 diabetes (T2D) is a costly epidemic, both in the U.S. and worldwide. Typically, it is managed with a
progressively escalating and complicated medication regimen, which presents challenges with respect to
adherence, cost, and side-effects. Lifestyle interventions are a potentially sustainable, less expensive solution
with positive side effects. The parent R01 grant reported that, compared to conventional weight loss therapy,
an intervention that focuses on reducing post-nutrient blood glucose (BG) excursions is effective at improving
metabolic control, risk for cardiovascular disease, depression, empowerment and diabetes distress. Efficacy was
unrelated to baseline demographic, psychological or disease severity variables, suggesting this approach is
broadly applicable. The current proposal differs from our previous research in that it will be a multi-center study
for greater external validity, individualized to more accurately reflect routine care, applied to adults newly
diagnosed with T2D, who may benefit the most, and it will be self-administered at home to eliminate the need
for face-to-face contact and consequently will be more broadly applicable.
200 adults who are newly diagnosed with T2D and have not begun taking diabetes medication will be randomized
to individualized medication management or to individualized post-nutrient glucose excursion minimization
(GEM). Medication management participants will receive from their primary care provider the medication types,
doses and timing that will optimize treatment and minimize side effects. The 4-session, self-administered GEM
will be individualized by allowing participants to choose between a text or video format, between continuous
glucose or capillary BG monitoring, and the timing and content of text-message prompts based on their
preference and resources. Participants will be assessed before, and at both 3 and 12 months post-treatment.
Assessments will include clinical (A1c, lipids, blood pressure, weight, risk of cardiovascular disease), behavioral
(physical activity, carbohydrate intake) and psychosocial (depression, empowerment, diabetes distress)
outcomes. Throughout the 12-month study period, each participant’s diabetes-related expenditures will be
tracked. We hypothesize that GEM will be superior to medication management in terms of reducing A1c, with
less diabetes medication, lower diabetes-related cost, and will lead to greater secondary benefits.
The results of this study have the potential to immediately provide patients newly diagnosed with T2D and their
primary care providers a new, cost-effective lifestyle intervention option. It could also direct researchers toward
investigating the maintenance of GEM’s impact and its underlying mechanisms (e.g. reducing insulin resistance,
glucose toxicity, improving insulin production).
