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

The purpose of this particular protocol is to study the underlying glycemic variability
across the menstrual cycle in women with T1DM. A subset of premenopausal women with T1DM
experience loss of glucose control during the latter half of the cycle (the luteal phase).
Clinical trials are sparse and tools are limited to focus on this aspect of diabetes care
which is highly relevant in affected individuals. To obtain data to initialize this
mobile-based module, we will enroll premenopausal women for approximately three-month
outpatient study designed to characterize at least three complete menstrual cycles. These
subjects will wear continuous glucose monitors (CGMs), record self-monitored blood glucoses
(SMBGs) and utilize an insulin pump to capture insulin dosing. In-home ovulation kits will be
used to determine relevant days for sex-steroid blood measurements to define menstrual cycle
phases. Finally, structured at-home meals will be provided during different phases of the
menstrual cycle for insulin action parameters assessments.

The software module will be developed in parallel with the data collection from study
subjects. The software module will not be used with the patients in this study as it is not
in existence as would be developed in parallel. The goal of the module functionality will be
to 1) assist patients and providers in the identification and management of glycemic
variability surrounding the menstrual cycle and 2) add value to and become an integral module
within the artificial pancreas.

Inclusion Criteria:

1. Premenopausal women with menstrual cycles that occur approximately every 20-40 days.

2. 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

3. Age ≥18 y.o. and ≤55 y.o.

4. Use of an insulin pump to treat their diabetes for at least 6 months.

5. Has an identified healthcare provider who can provide advice about diabetes care.

6. Actively using a current insulin pump with pre-defined parameters for glucose goal,
carbohydrate ratio, and insulin sensitivity factor.

7. Willingness to do additional fingersticks when requested such as when CGM alarms at
low or high end (<70 mg/dl or >300 mg/dl),

8. Willingness to come to Center for Diabetes Technology for study visits.

9. Willingness to avoid consumption of acetaminophen-containing products for the duration
of the study.

10. Demonstration of proper mental status and cognition for completion of the study.

11. Hemoglobin A1c 5-10%

Exclusion Criteria:

1. Pregnant or intending to get pregnant during study

2. Active enrollment in another clinical trial

3. Medical requirement for acetaminophen-containing products during the study period for
more than 1 week

4. Use of medication or intervention that significantly alters the menstrual cycle such
as oral contraceptives, depoprovera, or intrauterine device (IUD).

5. 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)

6. 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.

7. Use of prednisone for more than 10 days during the study.

8. Uncontrolled thyroid disease

9. Clinical diagnosis of polycystic ovarian syndrome requiring treatment.

10. Significant elevation in liver function tests (e.g. >2-3 times normal), known
infectious hepatitis or HIV.

11. History of a systemic deep tissue infection with methicillin-resistant staph aureus or
Candida albicans

12. Known bleeding diathesis or dyscrasia

13. Active renal dialysis

14. Individuals with cognitive impairment that prevents understanding either consent form
or intervention content

15. Psychiatric disorders that would interfere with study tasks (e.g., substance
abuse)-self reported

List any restrictions on use of other drugs or treatments.

1. Acetaminophen with the use of the CGM.

2. Use of medication or intervention that significantly alters the menstrual cycle such
as oral contraceptives, depoprovera, or IUD.

3. Anticipate need for MRI/MRA during the study. Unplanned MRI/MRA requiring temporary
interruption of CGM use would be allowed.

4. Use of prednisone for more than 10 days during the study.