NCT04897945Active, not recruiting
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 18 May 2021
- Start date
- 12 Oct 2021
- Primary completion date
- 25 Jun 2025
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Type 2 diabetes
- NCT number
- NCT04897945
What you commit to
- Study type: Interventional
- Planned participants: 310
- From 12 Oct 2021 to the primary completion date, 25 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any anti-glycemic medications or insulin use 12 months prior to randomization
- History of any type of weight loss surgery 12 months prior to randomization
- Completed a prior prediabetes SDM consult anytime
- 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
Other illness
- Currently being treated for an eating disorder, such as anorexia or bulimia
- Currently enrolled OR have ever participated in any CDC certified Diabetes Prevention Program (DPP)
- History of metformin intolerance
Lab values
- 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)
- Most recent eGFR \<45 ml/min
Other
- Delivery within the last 12 months at randomization
- BMI \>60 kg/m2 at randomization
- Currently pregnant or planning to get pregnant in the next 12 months
- Unable to attend 3 virtual or in-person visits over the next 2 years at UCLA or Intermountain Healthcare
- Non-English primary language
Who the study is looking for
- 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
Age in the registry: 18 years to 54 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Intermountain Healthcare System Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.