Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01441518
Eligibility Criteria:
Inclusion Criteria:
* Patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. Patients should have one of the four criteria as following:
* Patients with positive screening for GDM presenting a TTG of 75 g and one of the values below:
* fasting glucose ≥ 92;
* 1h ≥ 180; or
* 2h ≥ 153 will be considered gestational diabetes mellitus (GDM) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. If the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or
* Patients with pre gestational diabetes mellitus type 1 or 2; or
* Patients with positive screening for GDM and presenting normal TTG of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( Rudge et al,1990).
* Normal TTG and an abnormal glycemic profile will be considered as mild gestational hyperglycemia
* Patient provided written informed consent.
Exclusion Criteria:
* Twin pregnancy diagnosed until the date of randomization or;
* Fetal malformation diagnosed until the date of randomization.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01441518
Study Brief:
Protocol Section:
NCT01441518