Shared Decision Making in Diabetes Prevention for Women With a History of GDM

Gestational Diabetes Clinical Trial

Official title:

Pilot Study of Pharmacist-Coordinated Implementation of the Diabetes Prevention Program (DPP) for Women With a History of Gestational Diabetes Mellitus (GDM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766256
• Other study ID #: IRB#18-001058
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 28, 2019

Study information

• Verified date: February 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Overweight or obese (BMI >25 or >23 if Asian American)

• at least 6 weeks post-partum

• have a history of gestational diabetes mellitus

Exclusion Criteria:

• Currently pregnant,

• not a UCLA Health patient

• any history of a Type 2 diabetes diagnosis, based on billing codes, laboratory values, or taking any antiglycemic medications

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Shared decision-making with pharmacists
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.

Locations

Country	Name	City	State
United States	Toluca Lake Health Center	Burbank	California
United States	100 Medical Plaza Primary Care Suites 455 & 490	Los Angeles	California
United States	CPN Brentwood	Los Angeles	California
United States	CPN West Washington Internal Medicine	Los Angeles	California
United States	Internal Medicine Women's Health Clinic Suites 250 & 290	Los Angeles	California
United States	UCLA Internal Medicine Family Westwood Suite 465	Los Angeles	California
United States	UCLA Internal Medicine Geriatrics Suite 365 & 420	Los Angeles	California
United States	Pacific Palisades	Pacific Palisades	California
United States	12th Street Clinic	Santa Monica	California
United States	CPN Santa Monica 15th Street Family Medicine Practice	Santa Monica	California
United States	CPN/Santa Monica Parkside	Santa Monica	California
United States	Santa Moica Bay Physicians Ocean Park	Santa Monica	California
United States	Santa Moica Bay Physicians/20th Street 10th Floor	Santa Monica	California
United States	Santa Monica Bay Physicians Plaza	Santa Monica	California
United States	Santa Monica Bay Physicians/20th Street 3rd Floor	Santa Monica	California
United States	Santa Monica Internal Medicine	Santa Monica	California
United States	UCLA Family Health Clinic	Santa Monica	California
United States	Wilshire Office	Santa Monica	California
United States	CPN Woodland Hills Practice	Woodland Hills	California
United States	Jack H. Skirball Health Center	Woodland Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choice of evidence-based diabetes prevention (lifestyle change or metformin)	One of four participant decisions: 1) choosing to attend a Centers for Disease Control and Prevention (CDC)-certified diabetes prevention program, 2) choosing to start metformin as diabetes prevention, 3) choosing both the diabetes prevention program and metformin, 4) choosing NOT to start either the diabetes prevention program or start metformin.	2 weeks
Secondary	Weight change	Change of weight as measured in the EHR	9 months
Secondary	Systolic blood pressure	Change in systolic blood pressure as measured in the EHR	9 months
Secondary	Decisional conflict	Three collaboRATE items that measure decisional conflict	2 weeks