NCT02693938

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
3.7 years until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

January 15, 2016

Last Update Submit

February 9, 2022

Conditions

Type 1 Diabetes

Keywords

diabetesmenstrual cycleinsulin

Outcome Measures

Primary Outcomes (3)

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

    The insulin glucodynamic action will be measured by the amount of dextrose infused during the study as previously described by DeFronzo. The primary outcome measure for the euglycemic clamp studies will be area under the glucose infusion rate (AUCGIR) that will be compared between luteal and follicular phases of menstrual cycle.

    Up to 30 days

  • Glucose Infusion Rate

    During the luteal phase of the menstrual cycle, subjects will go through an insulin time action (clamp) study. Subjects are injected a bolus dose of insulin and blood sugar levels are kept within a 90-100mg/dL range by intravenous fluid infusion during fasting state. GIR stands for the glucose infusion rate that is measured in mg/kg/minute, indicating the amount of glucose delivered per minute per kilogram of body mass.

    Up to 15 days

  • Glucose Infusion Rate

    During the follicular phase of the menstrual cycle, subjects will go through an insulin time action (clamp) study. Subjects are injected a bolus dose of insulin and blood sugar levels are kept within a 90-100mg/dL range by intravenous fluid infusion during fasting state. GIR stands for the glucose infusion rate that is measured in mg/kg/minute, indicating the amount of glucose delivered per minute per kilogram of body mass.

    Up to 15 days

Other Outcomes (1)

  • Glycemic variability

    Up to 30 days

Study Arms (2)

luteal phase clamp

EXPERIMENTAL

Luteal euglycemic clamp administered during luteal phase of menstrual cycle.

Device: Luteal Euglycemic clamp

follicular phase clamp

ACTIVE COMPARATOR

Follicular euglycemic clamp administered during follicular phase of menstrual cycle.

Device: Follicular Euglycemic clamp

Interventions

Follicular Euglycemic clampDEVICE

Follicular Euglycemic clamp during follicular phase

follicular phase clamp
Luteal Euglycemic clampDEVICE

Luteal Euglycemic clamp during luteal phase

luteal phase clamp

Eligibility Criteria

Age12 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Publications (1)

  • 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.

    PMID: 35714349DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • Eda Cengiz, MD, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

February 29, 2016

Study Start

November 13, 2019

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)