Status:
ACTIVE_NOT_RECRUITING
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Intermountain Health Care, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gestational Diabetes Mellitus
Pre-diabetes
Eligibility:
FEMALE
18-54 years
Phase:
NA
Brief Summary
Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM...
Detailed Description
Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM) but evidence from the Diabetes Prevention Program (DPP) indicates that lifestyle chang...
Eligibility Criteria
Inclusion
- 18 years to 54 (Adult)
- Females
- Most recent BMI ≥25 kg/m2 (or \>23 if Asian American)
- History of gestational diabetes mellitus based on:
- Diagnostic code ICD10 or 1-hour glucose challenge test \> 140 mg/dL, followed by 3-hour glucose tolerance test with TWO or more values. Cut-offs \>= i. 95 at 0-hour ii. 180 at 1-hour iii. 155 at 2-hour iv. 140 at 3-hour
- History of prediabetes in prior 36 months defined by either
- most recent HbA1c 5.7-6.4% or
- most recent FPG 100-125 mg/dL or
- prior diabetes diagnostic codes + abnormal labs
- Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months
Exclusion
- Delivery within the last 12 months at randomization
- History of diabetes (i.e., prior HbA1c 6.5% or above, or 2 or more fasting plasma glucose 125 or above, or prior diagnostic code)
- Any anti-glycemic medications or insulin use 12 months prior to randomization
- Most recent eGFR \<45 ml/min
- BMI \>60 kg/m2 at randomization
- History of any type of weight loss surgery 12 months prior to randomization
- Currently being treated for an eating disorder, such as anorexia or bulimia
- Currently pregnant or planning to get pregnant in the next 12 months
- Completed a prior prediabetes SDM consult anytime
- Currently enrolled OR have ever participated in any CDC certified Diabetes Prevention Program (DPP)
- Inability or concerns about doing \>150 minutes of physical activity per week Currently taking a medication called metformin or have been prescribed metformin in the last 12-months
- History of metformin intolerance
- Unable to attend 3 virtual or in-person visits over the next 2 years at UCLA or Intermountain Healthcare
- Non-English primary language
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04897945
Start Date
October 12 2021
End Date
October 1 2026
Last Update
July 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Los Angeles
Los Angeles, California, United States, 90024
2
Intermountain Healthcare System
Salt Lake City, Utah, United States, 84103