Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes

Inclusion Criteria

• Premenopausal women with menstrual cycles that occur approximately every 20-40 days.
• T1DM (as defined by the American Diabetes Association criteria or judgment of a physician) for at least 2 years prior to the enrollment in the study
• Age ≥18 y.o. and ≤55 y.o.
• Use of an insulin pump to treat their diabetes for at least 6 months.
• Has an identified healthcare provider who can provide advice about diabetes care.
• Actively using a current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
• Willingness to do additional fingersticks when requested such as when CGM alarms at low or high end ( 300 mg/dl),
• Willingness to come to Center for Diabetes Technology for study visits.
• Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.
• Demonstration of proper mental status and cognition for completion of the study.
• Hemoglobin A1c 5-10%

Exclusion Criteria

• Pregnant or intending to get pregnant during study
• Active enrollment in another clinical trial
• Medical requirement for acetaminophen-containing products during the study period for more than 1 week
• Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD).
• Medical condition that would make operating a CGM or insulin pump difficult (e.g. blindness, severe arthritis, extensive scar tissue at sites where devices are inserted)
• Anticipated need for Magnetic resonance imaging (MRI)/Magnetic resonance angiography (MRA) during the study. Unplanned MRI/MRA requiring temporary interruption of CGM use would be allowed.
• Use of prednisone for more than 10 days during the study.
• Uncontrolled thyroid disease
• Clinical diagnosis of polycystic ovarian syndrome requiring treatment.
• Significant elevation in liver function tests (e.g. >2-3 times normal), known infectious hepatitis or HIV.
• History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
• Known bleeding diathesis or dyscrasia
• Active renal dialysis
• Individuals with cognitive impairment that prevents understanding either consent form or intervention content
• Psychiatric disorders that would interfere with study tasks (e.g., substance abuse)-self reported

List any restrictions on use of other drugs or treatments.

• Acetaminophen with the use of the CGM.
• Use of medication or intervention that significantly alters the menstrual cycle such as oral contraceptives, depoprovera, or IUD.
• Anticipate need for MRI/MRA during the study. Unplanned MRI/MRA requiring temporary interruption of CGM use would be allowed.
• Use of prednisone for more than 10 days during the study.