Clinical trial NCT02693938: Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes
Official title: Investigating Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes to Design Innovative Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: diabetes
menstrual cycle
insulin
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2016-02-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in area under the glucose infusion rate (AUCGIR) during different phases of menstrual cycle
timeFrame: Up to 30 days
measure: Glucose Infusion Rate
timeFrame: Up to 15 days
measure: Glucose Infusion Rate
timeFrame: Up to 15 days
Secondary outcomes:
Other outcomes:
measure: Glycemic variability
timeFrame: Up to 30 days
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Eda Cengiz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz C JL, Fabris C, Breton MD, Cengiz E. Insulin Replacement Across the Menstrual Cycle in Women with Type 1 Diabetes: An In Silico Assessment of the Need for Ad Hoc Technology. Diabetes Technol Ther. 2022 Nov;24(11):832-841. doi: 10.1089/dia.2022.0154.