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 range

12 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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