Shared Decision Making in Diabetes Prevention for Women With a History of GDM
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Gestational diabetes mellitus (GDM) is a risk factor for the development of Type 2 diabetes.
      Lifestyle change and metformin are equally effective in preventing diabetes in patients with
      a history of GDM, so these women should choose a strategy based on their preferences and
      values, which may vary by race/ethnicity. This proposal will engage 32 women in shared
      decision making about diabetes prevention.
    

Detailed description: 
      The Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle change and
      metformin both prevent or delay Type 2 diabetes (T2DM), but uptake of either approach has
      been minimal. The research team is implementing a shared decision-making (SDM) intervention
      for diabetes prevention funded by the National Institute of Diabetes and Digestive and Kidney
      Disease (NIDDK; R18 DK105464). In this clinic-based pragmatic trial, the Prediabetes Informed
      Decisions and Education (PRIDE) study, pharmacists engage patients with prediabetes in
      evidence-based diabetes prevention using an SDM framework. The research team reached the
      recruitment goal (n=350) more than 15 months ahead of schedule and enrolled 1.5 times the
      number of projected participants (n=515), including 56% from racial/ethnic minority groups.
      PRIDE has been highly successful in treatment engagement, as 85% of participants chose either
      lifestyle change or metformin. Furthermore, among patients who have reached 12-month
      follow-up, PRIDE participants as a group have lost more weight than matched controls (-5.2
      lbs. vs. -0.29 lbs., p<0.001).

      PRIDE targets both men and women with prediabetes. Only five PRIDE participants had a history
      of gestational diabetes mellitus (GDM) during a prior pregnancy. GDM is more common among
      minority women and a history of a GDM diagnosis is one of the most significant risk factors
      for incident type 2 diabetes, increasing the risk of developing T2DM upwards of sevenfold.
      The research team is planning to pilot an SDM intervention for women with a history of GDM.
      This project would advance a patient-centered approach to increase uptake of both
      evidence-based diabetes prevention strategies among the subgroup of minority women at the
      highest risk of progression to T2DM.

      In the proposed project, the research team plans to enroll women with a history of GDM in a
      pilot study, tracking their choice of diabetes prevention strategy and their weight change
      over time. Importantly, the pilot will enable the research team to estimate the sample size
      for a future, multi-center study to engage women with a history of GDM in SDM for diabetes
      prevention. The project's specific aim is as follows:

      In a pilot study, to deliver the tailored intervention to a diverse sample of 32 women with a
      history of GDM and hemoglobin A1c from 5.7-6.4% who have not yet developed Type 2 diabetes,
      with a sample divided equally between whites, African Americans, Latinas and Asian Americans
    

Intervention name(s): Shared decision-making with pharmacists
Intervention type(s): Behavioral
Intervention description(s): Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention