CompletedNot Applicable

Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes

United States28 participantsStarted 2019-11-13

Plain-language summary

This research study is designed to look at differences in responsiveness to the subcutaneous injection of a standardized dose of rapid-acting insulin analog and blood glucose variability during different phases of the menstrual cycle in females with type 1 diabetes (T1D).

Who can participate

Age range12 Years – 35 Years

SexFEMALE

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Inclusion criteria

✓. Age 12-35
✓. diagnosis of T1D\>1year;
✓. BMI%\<85th;
✓. HbA1c \<9%.
✓. Subjects ages 21-35y on combination oral contraceptive pills (OCP) could be included.

Exclusion criteria

✕. irregular periods,
✕. pregnant, breastfeeding,
✕. subjects\>20y on progesterone only pills or injections,
✕. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol,
✕. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, including blood glucose monitoring requirements including the documentation of blood glucose data and insulin dosing,and/or inability to return for follow-up visits, and unlikely to complete the study.
✕. Subjects on OCP will be excluded in the 12-20y group to capture the physiologic variability in insulin action during pubertal progress.

What they're measuring

The change in area under the glucose infusion rate (AUCGIR) during different phases of menstrual cycle

Timeframe: Up to 30 days

Glucose Infusion Rate

Timeframe: Up to 15 days

Glucose Infusion Rate

Timeframe: Up to 15 days

Trial details

NCT IDNCT02693938

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-07

View on ClinicalTrials.gov More Type 1 Diabetes trials