Contraception in type 1 diabetes

Metabolic effect of the long-acting reversible contraceptive method (implant) compared to combined oral contraceptive in young women with type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29256651

Enrollment

Registered

2017-06-27

Start date

2017-07-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Young women with type 1 diabetes or healthy controls. Nutritional, Metabolic, Endocrine Type 1 diabetes

Interventions

Healthy participants and participants with T1D (N:40) seeking contraception are recruited. Counseling about contraception and pregnancy prevention is given to both groups of women. Participants are o

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Inflammatory markers is measured using C-Reactive Protein Levels at baseline, three, six, and 12 months 2. Metabolic control (HbA1c) is measured using HbA1c with DCA-2000 (Siemens) equipment at month three, six, nine and 12 3. Bone Mass is measured using DXA (Lunar Prodigy GE) at baseline, 12 and 24 months 4. Insulin sensitivity is measured using estimated insulin sensitivity index, which includes the measurement of adiponectin and was validated for subjects with and without T1D6 at baseline, three, six, and 12 months 5. Telomere length is measured using blood tests at baseline and at 12 months	—

Measure

Time frame

1. Inflammatory markers is measured using C-Reactive Protein Levels at baseline, three, six, and 12 months 2. Metabolic control (HbA1c) is measured using HbA1c with DCA-2000 (Siemens) equipment at month three, six, nine and 12 3. Bone Mass is measured using DXA (Lunar Prodigy GE) at baseline, 12 and 24 months 4. Insulin sensitivity is measured using estimated insulin sensitivity index, which includes the measurement of adiponectin and was validated for subjects with and without T1D6 at baseline, three, six, and 12 months 5. Telomere length is measured using blood tests at baseline and at 12 months

—

Secondary

Measure	Time frame
1. Metabolic control will be assessed at 18 and 24 months in women with type 1 diabetes 2. Bone mass DXA (Lunar Prodigy GE) and insulin sensitivity in all the participants is assessed using DXA (Lunar Prodigy GE) and insulin sensitivity index at 24 months of treatment	—

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026