Development of a Behavioral Observer for Type 1 Diabetes Mellitus (Phase1)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Boris Kovatchev, PhD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01434030
First received: September 12, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well as translational modeling and engineering development. In order to be successful, closed-loop control in Type 1 Diabetes Mellitus (T1DM) must adapt to individual physiologic characteristics and to the behavioral profile of each person. An essential part of this adaptation is biosystem (patient) observation. The investigators propose to lay the foundation for a closed-loop control system which will include algorithmic observers of patients' behavior and metabolic state.


Condition Intervention
Diabetes Mellitus, Type 1
Behavioral: Focus Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of a Behavioral Observer for Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Desire to Receive Advice From Personal Glucose Advisory System (PGASystem) [ Time Frame: 2 hour focus group ] [ Designated as safety issue: No ]
    The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would like to receive this type of information from a PGASystem.


Secondary Outcome Measures:
  • Willingness to Follow PGASystem Advice [ Time Frame: 2 hour focus group ] [ Designated as safety issue: No ]
    The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would follow this type of advice from a PGASystem.


Enrollment: 57
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Behavioral Observer
Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
Behavioral: Focus Group
Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.

Detailed Description:

This intensive descriptive study will follow 60 adults with T1DM who are currently experienced with insulin pump use for a two-week training period plus a one month active study period during which the DexCom SEVEN® PLUS Continuous Glucose Monitor (CGM) will be used in tandem with the OmniPod® Insulin Management System. The OmniPod® has a built in FreeStyle glucometer that allows tagging of food and activity-related treatment behaviors with each self-monitoring blood glucose (SMBG) value. The OmniPod® personal digital assistant (PDA) also stores information about insulin delivery and meal size in relation to the carbohydrate content. Parallel recording of CGM and behavioral data, as well as psychometric instruments will produce a rich synchronized data set for each person that will ultimately lead to the development of a behavioral event generator for use in future open-loop and closed-loop control algorithms for intelligent insulin dosing.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 Diabetes Mellitus (as defined by the American Diabetes Association criteria or judgment of a physician) for at least two years prior to the enrollment in the study.
  • Use of an insulin pump to treat their diabetes for at least six months.
  • Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
  • Age 21 - 65 years. The investigators will not be studying children since the DexCom Seven® Plus is not approved for use in children. Adults over age 65 are likely to have medical exclusions for the follow-up Phase 2 study, which involves induced hypoglycemia.
  • Willingness to participate in the study for 6 weeks wearing a DexCom Seven® Plus CGM and OmniPod® insulin pump, performing self-monitoring blood glucose (SMBG) with the integral FreeStyle glucometer 4 times per day (before meals and bedtime) in addition to SMBG required to calibrate the CGM or to validate a low or high BG alarm (<70 mg/dl or >300 mg/dl), and recording behavioral events by tagging SMGB values throughout the study with meal and activity descriptors.
  • 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.

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disorders that would interfere with study tasks (e.g. mental retardation, substance abuse)
  • History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
  • Known bleeding diathesis or dyscrasia
  • Active enrollment in another clinical trial
  • Medical requirement for acetaminophen-containing products during the study period for more than 1 week
  • 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).
  • Need for magnetic resonance imaging (MRI)/magnetic resonance angiogram (MRA) during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434030

Locations
United States, Virginia
University of Virginia - Center for Diabetes Technology
Charlottesville, Virginia, United States, 22901
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Boris P Kovatchev, Ph.D. University of Virginia
  More Information

Publications:
Responsible Party: Boris Kovatchev, PhD, Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01434030     History of Changes
Other Study ID Numbers: 14956, R01DK085623
Study First Received: September 12, 2011
Results First Received: August 8, 2014
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014