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

NCT01653210 | Completed Results

• 1 other identifier: 16272
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Insulin Pump; Continuous Glucose Monitor; Premenopausal women

Outcome Measures

Primary Outcomes (1)

• High Blood Glucose Index (HBGI)

  Measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia. Our primary outcome measure is hyperglycemia risk during the luteal phase of the menstrual cycle. The primary hypothesis is there is an increased hyperglycemia risk during the luteal phase when compared to the follicular phase. Subjects will be compared to themselves across the three menstrual cycles captured. Hyperglycemia will be primarily assessed by high blood glucose index which was assessed over 3 menstrual cycles at specific time points in the cycle.

  Three menstrual cycles (average length of one cycle was 28.7 days)

Secondary Outcomes (1)

• Glycemic Changes During Luteal Phase

  Three Menstrual Cycles

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

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

Sponsors & Collaborators

• University of Virginia: lead
• LifeScan: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sue Brown, MD
• Organization: Univerisity of Virginia

sab2f@virginia.edu

Study Officials

• Sue A. Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)