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

NCT04665999 | Completed

• 1 other identifier: 190046
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Menstrual Cycle; Continuous Glucose Monitor (CGM); Oral contraceptives; Free cycling

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity computed using a Kalman filter-base algorithm embedding a model of glucose-insulin dynamics.

  Primary Variable

  3 months

Study Arms (2)

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

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

Interventions

Continuous Glucose Monitor DEVICE

Data collection only

Females taking Monophasic contraception; Free-cycling females

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Regularly menstruating females (at least every month with no missed cycles)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chiara Fabris, PhD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: January 15, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

US (1)