Brief Summary

This proposed project will translate evidence-based strategies for diabetes prevention within the framework of an existing and highly utilized pharmacist-led diabetes care program. Our team includes investigators and practitioners with experience in implementing the DPP (Diabetes Prevention Program) as well as in community-based research. This proposal represents an opportunity to rapidly implement an innovative project addressing a critical area of significant unmet need, as the required key health system and community infrastructure are already in place. The intended outcome is the creation of a practical, effective and sustainable approach to increase evidence-based diabetes prevention strategies that can readily be adopted in other systems.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

521

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

March 4, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed

Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

March 4, 2015

Last Update Submit

September 26, 2019

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

Uptake of evidence-based diabetes prevention (lifestyle change or metformin)
Either attending 4/16 or 9/16 lifestyle change sessions, or taking metformin
4 months

Secondary Outcomes (3)

Weight change
12 months
Change in A1c
12 months
Change in systolic blood pressure
12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Pharmacist-coordinated shared decision making about treatment for pre-diabetes (lifestyle change and/or metformin), using a decision tool

Behavioral: Shared decision-making with pharmacists

Usual Care

PLACEBO COMPARATOR

Usual care for patients with a diagnosis of pre-diabetes

Other: Standard care from primary care providers

Interventions

Shared decision-making with pharmacistsBEHAVIORAL

Pharmacist will engage patient using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change with a goal of 7% weight loss or metformin. Patients interested in 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

Standard care from primary care providersOTHER

Primary care providers address pre-diabetes as part of usual care, which may involve no action, referrals, or treatment with medications.

Usual Care

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

BMI (Body Mass Index) of \>=24 (\>=22 for Asians)
Prediabetes based on A1c values of 5.7-6.4%

You may not qualify if:

Any recorded A1c values of \>6.5%
ICD-9 billing codes of 250.xx
Use of any antiglycemic medication
Current or past participation in the Diabetes Prevention Program prior to providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Toluca Lake Health Center

Burbank, California, 91505, United States

Location

100 Medical Plaza Primary Care Suites 455 & 490

Los Angeles, California, 90024, United States

Location

Internal Medicine Women's Health Clinic Suites 250 & 290

Los Angeles, California, 90024, United States

Location

UCLA Internal Medicine Family Westwood Suite 465

Los Angeles, California, 90024, United States

Location

UCLA Internal Medicine Geriatrics Suite 365 & 420

Los Angeles, California, 90024, United States

Location

CPN Brentwood

Los Angeles, California, 90049, United States

Location

CPN West Washington Internal Medicine

Los Angeles, California, 90066, United States

Location

Pacific Palisades

Pacific Palisades, California, 90272, United States

Location

12th Street Clinic

Santa Monica, California, 90401, United States

Location

Wilshire Office

Santa Monica, California, 90401, United States

Location

CPN Santa Monica 15th Street Family Medicine Practice