Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fifteen premenopausal women with menstrual cycles, 18-55 years of age, who have been
        diagnosed as type 1 diabetic for at least 2 years. Actively using a current insulin pump
        for the past 6 months with pre-defined parameters for glucose goal, carbohydrate ratio, and
        insulin sensitivity factor. Use of medication or intervention that significantly alters the
        menstrual cycle such as oral contraceptives, depoprovera, or intrauterine device (IUD)is
        prohibited.
      
Biospecimen description: 
      At each follow-up visit #3-13, blood will be taken to sample estradiol, progesterone,
      luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone and
      sex-hormone binding globulin (SHBG). At the end of study visit #14, a hemoglobin A1c will be
      measured.
    
Keywords: Insulin Pump; Continuous Glucose Monitor; Premenopausal women