An observational study in Type 1 Diabetes, Preeclampsia and Preeclampsia (PE) Risk, sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer. Not yet recruiting at 2 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Institut d'Investigacions Biomèdiques August Pi i Sunyer · Observational
This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy.
Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.
Preeclampsia (PE) is associated with increased long-term cardiovascular disease (CVD) risk. Women with type 1 diabetes (T1D) are at particularly high risk of both obstetric and cardiovascular complications.
Although clinical PE has been associated with subclinical carotid atherosclerosis and future cardiovascular events in women with T1D, it is unknown whether estimated first-trimester PE risk identifies a subgroup at increased long-term cardiovascular risk, regardless of the development of clinical PE.
Participants will be women with T1D followed in endocrinology clinics across Spain. Eligible participants must have undergone first-trimester PE screening (\<14 weeks gestation) in at least one pregnancy and be at least 3 years from their last delivery.
The primary exposure variable is first-trimester estimated PE risk (high vs low). Outcomes include subclinical carotid atherosclerosis, cardiometabolic risk profile, and incident cardiovascular events. Secondary outcomes include glycemic metrics from continuous glucose monitoring, cardiovascular health score (Life's Essential 8), patient-reported outcomes, and the effectiveness of aspirin in preventing clinical PE.
Data will be collected in a single study visit using medical records, physical examination, validated questionnaires, and carotid ultrasound (in centers with availability).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Institut d'Investigacions Biomèdiques August Pi i Sunyer is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with type 1 diabetes followed in endocrinology clinics who had at least one previous pregnancy with documented first-trimester preeclampsia screening.
Exclusion Criteria:
Women with type 1 diabetes classified as high risk for preeclampsia during first-trimester screening in at least one prior pregnancy.
Women with type 1 diabetes classified as low risk for preeclampsia during first-trimester screening in at least one prior pregnancy.
Number of carotid plaques
Presence of focal carotid plaque defined as focal wall thickening ≥1.5 mm detected by standardized 2D carotid ultrasound.
Time frame: At study visit (≥3 years postpartum)
Hemoglobin A1c (HbA1c)
HbA1c measured at study visit
Time frame: At study visit (≥3 years postpartum)
Lipid profile
Total cholesterol, triglycerides, HDL-cholesterol and Lipoprotein(a) measured directly. LDL-cholesterol estimated using the Friedewald formula.
Time frame: At study visit (≥3 years postpartum)
Blood pressure
Systolic blood pressure and diastolic blood pressure.
Time frame: At study visit (≥3 years postpartum)
Body mass index
Calculated as weight (in kg) / height (in meters) \^2
Time frame: At study visit (≥3 years postpartum)
Diabetic-related chronic microvascular complications
Defined as diabetic retinopathy, chronic kidney disease or diabetic neuropathy
Time frame: From the last pregnancy to the study visit (≥3 years postpartum)
Incident cardiovascular events
Composite of coronary artery disease, cerebrovascular disease, peripheral artery disease, or heart failure occurring between last pregnancy and study evaluation.
Time frame: From last pregnancy to study visit (minimum 3 years)
Carotid intima-media thickness
Measured by 2D ultrasonography
Time frame: At study visit (≥3 years postpartum)
Clinical diagnosis of preeclampsia in any pregnancy
Preeclampsia diagnosis will follow the international criteria (Obstet Gynecol. 2020;135(6):e237-e260)
Time frame: At study visit (≥3 years postpartum)
Ambulatory glucose profile (continuous glucose monitoring)
Time-in-range (%), Time-below-range (%), Time-above-range (%), Glucose management indicator (%), Coefficient of variation (%), mean glucose (mg/dL)
Time frame: Three months prior to study visit
Cardiovascular Health Score
Assessed using the American Heart Association (AHA) Life's Essential 8. This score ranges from 0 to 100, with higher values indicating better cardiovascular health.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Hypoglycemia Fear Survey (HFS)
Using the Spanish version of the scale (Tasende C et al. Endocrinol Diabetes Nutr 2018;65:287-296). The score ranges from 24 to 120, with higher values indicating more fear to hypoglycemia.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Clarke Score
Using the Spanish version of the scale (Jansà M et al. Med Clin 2015;145:511-516). The score ranges from 0 to 7, with higher values indicating less awareness to hypoglycemia.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Quality of Life questionnaire (DQoL)
Using the Spanish version of the scale (Millán MM et al. Endocrinol Nutr. 2002;49:2-8). Higher values indicates better quality of life.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Pittsburgh Sleep Quality Index (PSQI)
Using the Spanish version of the scale (Royuela A, Macías JA. Psiquis. 1997;18:337-343). The total score ranges from 0 to 21, with a score of 5 or higher indicating poor sleep quality.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Diabetes Distress Scale (DDS)
Reference: Fisher L et al. J Diabetes Complications 2015;29(4):572-7. Higher scores indicate greater levels of diabetes-related distress.
Time frame: At study visit (≥3 years postpartum)
Patient-reported outcomes. Problem Areas in Diabetes scale (PAID)
Using the Spanish version of the scale (Beléndez M et al. Diabetes Research and Clinical Practice. 2014;106: e93-e95). The total score ranges from 0 to 100, with higher scores indicating poor quality of life.
Time frame: At study visit (≥3 years postpartum)
Plan to share: No — Individual participant data (IPD) will not be shared due to data protection and confidentiality restrictions under the European Union General Data Protection Regulation (EU GDPR 2016/679) and Spanish Organic Law 3/2018 on Personal Data Protection. Although data collected in this study will be coded, the combination of detailed clinical, obstetric, and cardiovascular variables in a relatively specific population (women with type 1 diabetes and prior pregnancy) may pose a potential risk of re-identification. Furthermore, participants provide informed consent for use of their data exclusively for the purposes of this research project and related ethically approved analyses. Data sharing beyond these conditions is not covered by the approved consent framework. Aggregated results will be made publicly available through scientific publications and conference presentations.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Institut d'Investigacions Biomèdiques August Pi i Sunyer