New study aims to unravel the mystery of PCOS in women with type 1 diabetes

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

1. Non--hyperandrogenic women with type 1 diabetes INCLUSION CRITERIA * Premenopausal women between 18 and 45 years old. * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency. * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion). * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry. * Menarche at least three years prior to study entry. EXCLUSION CRITERIA * Honeymoon period of T1D. * Pregnancy or lactation. * Thyroid hormone dysfunction or hyperprolactinaemia. * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism. * Diagnosis of other serious chronic disease. * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study. 2. Women with type 1 diabetes and polycystic ovary syndrome INCLUSION CRITERIA * Women between 18 and 45 years old. * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency. * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion). * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry. * Menarche at least three years prior to study entry. * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS. EXCLUSION CRITERIA * Honeymoon period of T1D. * Pregnancy/lactation. * Thyroid hormone dysfunction or hyperprolactinaemia. * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism. * Diagnosis of other serious chronic disease. reatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study. 3. Men with T1D and normal gonadal function of similar age, BMI, and duration of diabetes. INCLUSION CRITERIA * Age between 18 and 45 years old. * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency. * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion). * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry. EXCLUSION CRITERIA * Honeymoon period of T1D. * Thyroid hormone dysfunction or hyperprolactinaemia. * Diagnosis of non-classical congenital adrenal hyperplasia. * Diagnosis of male hypogonadism. 4. Women with PCOS of similar age and BMI. INCLUSION CRITERIA * Women between 18 and 45 years old. * Menarche at least three years prior to study entry. * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS. EXCLUSION CRITERIA * Pregnancy/lactation. * Previously known carbohydrate metabolism abnormalities (prediabetes or type 2 diabetes). * Thyroid hormone dysfunction or hyperprolactinaemia. * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism. * Diagnosis of other serious chronic disease. * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study. 5. Non-hyperandrogenic control women with regular menses of similar age and BMI. INCLUSION CRITERIA * Women between 18 and 45 years old. * Menarche at least three years prior to study entry. * Presence of regular menses. * Lack of signs or symptoms of functional hyperandrogenism. EXCLUSION CRITERIA * Pregnancy/lactation. * Previously known carbohydrate metabolism disturbances. * Thyroid hormone dysfunction or hyperprolactinaemia. * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism. * Diagnosis of other serious chronic disease. * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.