A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

Running, not enrolling · Not applicable

Conditions studied: Gestational Diabetes Mellitus, Pre-diabetes, Diabetes Mellitus, Type 2

In brief

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) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

Key facts

Study ID

NCT04897945

Run by

University of California, Los Angeles

People needed

310

Starts

2021-10-12

Expected to finish

2026-10-01

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older, up to 54. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Intermountain Healthcare System — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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