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

Yale University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Luteal Euglycemic clamp; Device: Follicular Euglycemic clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT02693938

1509016531

Details and patient eligibility

About

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).

Full description

Type 1 Diabetes (T1D) is a chronic disease that leads to disability and premature death if not well treated. While females and males are equally affected by T1D, diabetes places additional burdens of care on females. Characteristically, females with T1D have worse glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of cardiovascular complications as compared to their male peers. It has been hypothesized that variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is an important underlying cause for increased management problems in females with T1D, but the hypothesis has not been adequately tested. Consequently, insulin treatment of females during the different cycles of menstruation remains a guessing game that often results in major swings in blood glucose from high to low levels. The unfavorable impact of this gap in knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (CL) system insulin delivery algorithms designed based on insulin action parameters. The proposed study addresses this unmet need in diabetes management for females both in open-loop (OL) and CL therapies.

Enrollment: 28 patients

Sex: Female

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. irregular periods,
2. pregnant, breastfeeding,
3. subjects>20y on progesterone only pills or injections,
4. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol,
5. 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.
6. Subjects on OCP will be excluded in the 12-20y group to capture the physiologic variability in insulin action during pubertal progress.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

luteal phase clamp

Experimental group

Description:

Luteal euglycemic clamp administered during luteal phase of menstrual cycle.

Treatment:

Device: Luteal Euglycemic clamp

follicular phase clamp

Active Comparator group

Description:

Follicular euglycemic clamp administered during follicular phase of menstrual cycle.

Treatment:

Device: Follicular Euglycemic clamp