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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK085623 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Observer | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris P Kovatchev, Ph.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia - Center for Diabetes Technology | Charlottesville | Virginia | 22901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22856588 | Result | 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. doi: 10.1089/dia.2012.0122. Epub 2012 Aug 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Observer | Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm - behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients' self-treatment behavior. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | 2 hour focus group |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Observer | Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm - behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients' self-treatment behavior. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris P Kovatchev, Ph.D. | University of Virginia | 434-924-5592 | bpk2u@virginia.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| HbA1c | Mean | Standard Deviation | percent glycated hemoglobin |
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| Duration of Diabetes | Time since diagnosis of Type 1 Diabetes | Mean | Standard Deviation | years |
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| 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. | Posted | Number | percentage of participants | 2 hour focus group |
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| 0 |
| 57 |
| 0 |
| 57 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
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