Contraception in type 1 diabetes

Not Applicable

Completed

• Conditions: Young women with type 1 diabetes or healthy controls.; Nutritional, Metabolic, Endocrine; Type 1 diabetes

• Registration Number: ISRCTN29256651
• Lead Sponsor: niversity of Chile

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38012981/ (added 30/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-27
• Study Completion: 2021-04-30
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

T1DM patients:
1. Clinical diagnosis of T1D is clear (patient received treatment with insulin from the time of diagnosis with clinical evidence of severe insulin deficiency).
2. Age: 16-25 years old.
3. Seeking contraception.
4. HbA1c lower than 13%
5. Has not used hormonal contraception for the last three months

Healthy subjects:
1. Age 16-25 years old
2. Seeking contraception
3. Has not used hormonal contraception for the last three months

Exclusion Criteria

Both groups of subjects (patients with type 1 diabetes and healthy controls):
1. Chronic conditions such as celiac sprue, epilepsy, cardiopulmonary or gastrointestinal conditions are present.
2. Use of steroidal medication.
3. Contraindications for using hormonal contraception (WHO criteria: migraine with aura, prothrombotic problems, etc)

Persons with type 1 diabetes:
1. HbA1c higher than 12.9%
2. Honeymoon period
3. Other type of diabetes

Healthy controls:
1. Menstrual cycle abnormalities according to the American Academy of Pediatrics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified