Development of a Behavioral Observer for Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

— Phase1  

Official title:

Development of a Behavioral Observer for Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434030
• Other study ID #: 14956
• Secondary ID: R01DK085623
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: August 25, 2014
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia - Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Shepard JA, Gonder-Frederick L, Vajda K, Kovatchev B. Patient perspectives on personalized glucose advisory systems for type 1 diabetes management. Diabetes Technol Ther. 2012 Oct;14(10):858-61. Epub 2012 Aug 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desire to Receive Advice From Personal Glucose Advisory System (PGASystem)	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.	2 hour focus group	No
Secondary	Willingness to Follow PGASystem Advice	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.	2 hour focus group	No