Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes

This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitor

Detailed Description

Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Center for Diabetes Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females between the ages of 18 and 40 with no signs of menopause either free cycling or taking a monophasic contraception.

Description

Inclusion Criteria:

• Type 1 diabetes for at least 12 months
• Use of glucose sensor in the last 6 months
• Use of insulin pump in the last 6 months
• Age ≥18 to ≤40 years
• HbA1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid HbA1c measurement, average blood glucose estimated from CGM data to be approximately 200 mg/dL or less
• Absence of perimenopausal/menopausal symptoms
• Willingness to keep track of beginning of menstrual cycle
• Willingness to keep track of ingested carbohydrates
• Willingness to not become pregnant during study participation
• Regularly menstruating (at least every month with no missed cycles)
• Only free-cycling participants: willingness to use ovulation kits to confirm ovulation
• Only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks of active pill and 1 week of placebo
• Willingness to use the study Dexcom G6 during the study
• Participants must have Internet access and a computer system that meets the requirements for uploading the study equipment

Exclusion Criteria:

• Pregnancy
• Hormonal birth control therapy except monophasic pill contraceptive
• Polycystic ovary syndrome (PCOS) diagnosis
• Current use of steroids
• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas, metformin)
• Uncontrolled thyroid disease
• Active fertility treatment
• Concomitant disease or condition that may compromise patient safety or ability to follow the protocol including: planned or current dialysis treatment; moderate to advanced nephropathy; known or suspected allergy to medical grade adhesives.
• Severe hypoglycemia or diabetes ketoacidosis (DKA) in the previous 6 months

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Free-cycling females; Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial.	Device: Continuous Glucose Monitor; Data collection only
Females taking Monophasic contraception; Continuous glucose monitor (CGM) data will be collected for three (3) full menstrual cycles. At the end of data collection, data will be analyzed to track insulin sensitivity and glycemic variability changes across the menstrual cycle. Participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. Participants will be asked to record dates of beginning of menses and ovulation. Participants will also be provide an activity tracker to wear during the duration of the trial.	Device: Continuous Glucose Monitor; Data collection only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.	Primary Variable	3 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Chiara Fabris, PhD, University of Virginia Center for Diabetes Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 25, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Menstrual Cycle; Continuous Glucose Monitor (CGM); Oral contraceptives; Free cycling
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 190046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No