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

This study has been completed.
Sponsor:
Collaborator:
LifeScan
Information provided by (Responsible Party):
Sue Brown, University of Virginia
ClinicalTrials.gov Identifier:
NCT01653210
First received: July 26, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of an Advisory System for Glycemic Control During the Menstrual Cycle in Patient With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Luteal Phase Hyperglycemic Risk [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Glycemic Changes during Luteal Phase [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Changes in estrogen and progesterone will be primary drivers of hyperglycemia risk during the luteal phase. These data will be analyzed as continuous variables.

  • Insulin Requirement during Menstrual Cycle [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Insulin requirements will increase during the luteal phase compared to the follicular phase.

  • Follicular Phase Hypoglycemia Risk [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    There is an increased hypoglycemia risk during the early follicular phase of the menstrual cycle. Variables assessed will include low blood glucose index (LBGI) and average daily risk ratio (ADRR).


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.


Enrollment: 15
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01653210

Locations
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22904
Sponsors and Collaborators
University of Virginia
LifeScan
Investigators
Principal Investigator: Sue M. Brown, MD University of Virginia
  More Information

No publications provided

Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT01653210     History of Changes
Other Study ID Numbers: 16272
Study First Received: July 26, 2012
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Insulin Pump
Continuous Glucose Monitor
Premenopausal women

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014