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

Completed

Conditions studied: Type 1 Diabetes Mellitus

In brief

This overall research goal will be to develop a mobile-based module to improve glycemic control during the menstrual cycle in women with Type 1 diabetes mellitus (T1DM). This module will run on an Android Operating System (OS) and will be available as: (i) a stand-alone application and (ii) an important additional component to a larger system, the Diabetes Assistant (DiAs) - a mobile-based medical platform for diabetes applications. This proposal aims to build one such application or module targeting the improvement of diabetes control in younger women who experience glucose variation related to their menstrual cycle.

Key facts

Study ID

NCT01653210

Run by

University of Virginia

People needed

15

Starts

2012-08-01

Expected to finish

2013-09-01

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 (<70 mg/dl or >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%

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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