Assessment of glucose levels and insulin requirements during the menstrual cycle in women with type 1 diabetes using an automatic insulin delivery system

Assessment of glucose levels and insulin requirements during the menstrual cycle in women using Medtronic 780G

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15462576

Enrollment

Registered

2024-11-18

Start date

2024-01-02

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Young adult and adolescent women with type 1 diabetes Nutritional, Metabolic, Endocrine

Interventions

Follow-up of women using an automated insulin delivery system (Medtronic 780G) that can deliver insulin as needed. T he researchers will assess glucose levels and insulin delivery in the luteal and fo

Eligibility

Sex/Gender

Female

Age

12 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of T1D is clear. Diagnosis of T1D will be based on the need for insulin treatment from the onset of the disease and clinical diagnosis of T1D. The characteristics of the menstrual cycle will not be an inclusion or exclusion criterion 2. Younger than 35 years of age. 3. Users of 780G 4. At least 2 years post-menarche 5. Willing to track menstrual cycles with an electronic app

Exclusion criteria

Exclusion criteria: 1. Amenorrhea (>90 days) during the last semester 2. Use of hormonal contraception 3. Subjects whose diagnosis of the type of diabetes is unclear will be excluded 4. The presence of the honeymoon period (10 IU/ml in the past year) 11. Hypogonadism, or other hormonal deficiencies

Design outcomes

Primary

Measure	Time frame
Continuous glucose monitoring will determine the ambulatory glucose profile (Guardian 3 or Guardian 4, Medtronic, Inc.), which measures interstitial glucose levels every five minutes. This data is downloaded to an online database (Carelink). The ambulatory glucose profile will be determined in the early follicular and late luteal phases for at least three menstrual cycles—the definition of the early follicular and late luteal phase. •The initiation of the bleeding will be considered day 1. Early follicular phase: days 1 to 4 of the cycle or 2-4 if initiation of bleeding is not precise. Late luteal phase: days -3 to -1 of the cycle The following variables will be obtained from the continuous glucose monitoring system and determined for the different menstrual cycles: 1.Time in range (proportion of time that the patient has interstitial glucose in the 70-180 mg/dl range) 2.Mean glucose levels: mean glucose level of the period. 3.Coefficient of glucose variability, 4.Time below range (<70 mg/dl)	—

Measure

Time frame

Continuous glucose monitoring will determine the ambulatory glucose profile (Guardian 3 or Guardian 4, Medtronic, Inc.), which measures interstitial glucose levels every five minutes. This data is downloaded to an online database (Carelink). The ambulatory glucose profile will be determined in the early follicular and late luteal phases for at least three menstrual cycles—the definition of the early follicular and late luteal phase. •The initiation of the bleeding will be considered day 1. Early follicular phase: days 1 to 4 of the cycle or 2-4 if initiation of bleeding is not precise. Late luteal phase: days -3 to -1 of the cycle The following variables will be obtained from the continuous glucose monitoring system and determined for the different menstrual cycles: 1.Time in range (proportion of time that the patient has interstitial glucose in the 70-180 mg/dl range) 2.Mean glucose levels: mean glucose level of the period. 3.Coefficient of glucose variability, 4.Time below range (<70 mg/dl)

—

Secondary

Measure	Time frame
The amount of extra insulin that the insulin infusion pump algorithm gives to achieve normal glucose levels will be determined in the follicular and luteal phases. This will be defined as the number of daily units of insulin and the proportion of the total basal insulin administration.	—

Countries

Chile

Contacts

Public ContactFranco Giraudo

francogiraudo@uchile.cl+56 (0)229770850

Outcome results

None listed

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