Status:
COMPLETED
Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
DexCom, Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
FEMALE
18-40 years
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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04665999
Start Date
January 15 2021
End Date
March 10 2022
Last Update
April 6 2022
Active Locations (1)
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1
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903