- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767831
Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22904
- University of Virginia Center for Diabetes Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
For this pilot trial, recruitment will ONLY occur through UVa's IRB-HSR #14263 Recruitment Database.
Inclusion criteria for subject to enroll:
- 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 21-65.
- Use of an insulin pump to treat their diabetes for at least 6 months.
- Use of a CGM for at least a 6 week period in the past 2 years.
- Has the ability to use a computer that is capable of running the Dexcom Data Manager 3 (DM3) software daily.
- Has regular access to the Internet.
- Has an identified healthcare provider who can provide advice about diabetes care.
- Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity factor.
- Willingness to participate in the study for 11 weeks wearing a DexCom CGM for the duration of the study and perform daily journaling of BG, pump activity, meals, physical activity, stress level and menstrual cycle for 3 weeks during the study intervention period.
- Willingness to do extra fingersticks when CGM alarms at low or high end (<70 mg/dl or >300 mg/dl),
- Willingness to come to Center for Diabetes Technology on at least two occasions to obtain and return supplies.
- 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.
- Has the ability to contact their own personal diabetes care team to have clinical questions answered about changes to diabetes treatment.
Exclusion Criteria:
- Individuals with cognitive impairment that prevents understanding either consent form or intervention content
- Active renal dialysis
- Psychiatric disorders that would interfere with study tasks (e.g., substance abuse)
- History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
- Known bleeding diathesis or dyscrasia
- 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
- 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)
- Individuals who do not have access to their diabetes care team to have clinical questions answered about changes in their diabetes treatment.
- Need for magnetic resonance imaging (MRI)/magnetic resonance angiogram (MRA)during the study
List any restrictions on use of other drugs or treatments:
The CGM must be removed prior to Magnetic Resonance Imaging and use of acetaminophen-containing medications while using the CGM sensor may affect the performance of the device. Therefore, MRI and products containing acetaminophen will be restricted. If either is required out of medical necessity, the DexCom® will be removed and participant will have the option of repeating the involved study week. If the medical condition requires use of acetaminophen for longer than 1 week, the participant will be dropped from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group A: CGM monitoring (1) vs Intervention
Participants will undergo a 1 week CGM monitoring period (session 1), followed by a 4 week intervention period using the iBOLUSED intervention.
The 4 week intervention period will be followed by an additional CGM monitoring period (session 2).
For those in Group A, we compare the data collection in CGM monitoring session 1 to the data collection in the intervention period.
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The intervention will involve daily diary data upload and daily simulation-based feedback based on the collected diary data.
Throughout the educational intervention, participants will record diary data every day through the use of a diary component in the internet-based system.
Diary entries include data on meals, physical activity, history of the insulin basal rate and insulin boluses given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable, menstrual cycle and any physical illness.
Participants will also upload data from the CGM via the Dexcom DM3 software or the Dexcom Studio Software.
Other Names:
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Group B: CGM monitoring (2) vs Intervention
Participants will undergo a 1 week CGM monitoring period (session 1), followed by a 4 week intervention period using the iBOLUSED intervention.
The 4 week intervention period will be followed by an additional CGM monitoring period (session 2).
For those in Group B, we compare the data collection in CGM monitoring session 2 to the data collection in the intervention period.
|
The intervention will involve daily diary data upload and daily simulation-based feedback based on the collected diary data.
Throughout the educational intervention, participants will record diary data every day through the use of a diary component in the internet-based system.
Diary entries include data on meals, physical activity, history of the insulin basal rate and insulin boluses given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable, menstrual cycle and any physical illness.
Participants will also upload data from the CGM via the Dexcom DM3 software or the Dexcom Studio Software.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Accuracy of Feedback and Intervention Feasibility
Time Frame: within 6 months of study conclusion
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We will assess the ability of our intervention to provide accurate, useful data to participants that can improve quality of life and educate patients regarding glycemic outcome based on participant feedback collected in focus groups, the post-intervention psychobehavioral assessment, and based on an analysis of the accuracy of the feedback data presented to users based on the input (diary) data.
A comparison of input diary data metrics (glucose and insulin data) to output feedback (BG risk profiles, glycemic variability metrics) will allow us to quantify this accuracy.
Feasibility of the intervention will be assessed through analysis of pre- and post- assessments, and through feedback provided by subjects during the focus group sessions.
A statistician with a background in qualitative data analysis will analyze the psychobehavioral assessment and focus group data.
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within 6 months of study conclusion
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Ability of Behavioral Intervention to Improve Glycemic Outcome
Time Frame: within 6 months of study conclusion
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Measure the ability of the simulation-based feedback system intervention to assist in improving the nominal glucose profile based on a pre- and post-intervention assessment of the data. We hypothesize that, compared to the use of CGM alone, the educational system will result in: A2.1: Increased time within target range, defined as 70-140mg/dl overnight and 70-180mg/dl during the day; A2.2: Reduced risk for hypoglycemia, specifically reduction in nocturnal hypoglycemic episodes; A2.3: Reduced postprandial glucose variability and avoidance of hypoglycemia 3-4 hours after a meal; and A2.4: Acceptance of the system feedback by patients. |
within 6 months of study conclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychobehavioral Data to Inform Closed Loop Control Aggressiveness
Time Frame: within 1 year of study conclusion
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Collection of psychobehavioral data on individuals' fear of hypo- and hyperglycemia, and connecting the influence of these factors on insulin therapy self-management can facilitate the individualization of controller aggressiveness in the development of a closed-loop system. We study the ability of the psychobehavioral data to facilitate the individualization of controller aggressiveness in the development of a closed-loop system. The data that is used for this analysis are collected in through the pre- and post-intervention psychobehavioral assessments. |
within 1 year of study conclusion
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Relationships Between Physiology and Behavior Transferred to In Silico Environment
Time Frame: within 2 years from study conclusion
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Collection of relevant data to establish relationships between behavior and physiology will allow to iteratively transfer, in simulation, the influence of behavioral triggers through individual physiological parameters and metabolic mechanisms, to the final element of BG fluctuation. The collected diary data will be used to establish relationships, specifically stochastic models, between behavioral events, physiology, and self-treatment. The models are developed based on the collected data and will be incorporated into the simulation environment to capture realistically physiologic response to behavior and self-treatment strategies. |
within 2 years from study conclusion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Linda Gonder-Fredrick, Ph.D., University of Virginia Center for Diabetes Technology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16226
- R01DK085623 (U.S. NIH Grant/Contract)
- DP3DK094331 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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