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

NCT ID: NCT02693938

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-13
• Study Completion Date: 2020-02-07

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

luteal phase clamp

Luteal euglycemic clamp administered during luteal phase of menstrual cycle.

Group Type: EXPERIMENTAL

Luteal Euglycemic clamp

Intervention Type: DEVICE

Luteal Euglycemic clamp during luteal phase

follicular phase clamp

Follicular euglycemic clamp administered during follicular phase of menstrual cycle.

Group Type: ACTIVE_COMPARATOR

Follicular Euglycemic clamp

Intervention Type: DEVICE

Follicular Euglycemic clamp during follicular phase

Interventions

Follicular Euglycemic clamp

Follicular Euglycemic clamp during follicular phase

Intervention Type: DEVICE

Luteal Euglycemic clamp

Luteal Euglycemic clamp during luteal phase

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eda Cengiz, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35714349 (View on PubMed)

Other Identifiers

1509016531

Identifier Type: -

Identifier Source: org_study_id