Evaluation of a Simulation-Based Educational Tool for Personalized Feedback in Insulin Therapy Management
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 5/3/2014 |
| Start Date: | March 2013 |
| End Date: | December 2013 |
| Contact: | Molly K. McElwee, RN, CDE |
| Email: | mkm6x@virginia.edu |
| Phone: | 434-982-3459 |
This study combines data collection and simulation-based education, and it will enroll up to
36 adults with T1DM who already have experience with insulin pump therapy and some
experience with CGM. The study will first track participants for of a 3-day CGM-training
period. The training period will be followed by a 1-week CGM monitoring and CGM data
collection period. Following the 1-week CGM monitoring-only portion of the study,
participants will begin the education intervention component of the study, referred to as
Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The
education intervention component is 4 weeks in length. The intervention will involve daily
diary data upload and daily simulation-based feedback based on the collected diary data.
During the first week (and for up to 2 weeks) of the intervention, participants will view
glycemic outcome data that represents the participant's hypo- and hyperglycemic risk
throughout the day, based on the CGM data collected during the CGM monitoring period. In the
next 2 weeks of the intervention, participants will have an opportunity to interact with the
internet-based system using a simulation-based tool designed to provide insight to the
participant regarding the different effects of modifications to insulin therapy. 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. Two assessments, one prior to the
intervention period and one following the intervention, will be administered to gather
relevant psychobehavioral information. Focus group sessions will be conducted at the end of
the study, which will allow for the collection of information regarding the effectiveness of
the Internet intervention and will provide insight for the design of future studies.
Parallel recording of CGM, insulin, and behavioral data, as well as psychometric
instruments, will produce a rich synchronized data set for each person that will facilitate
the development of personalized behavioral profiles that will be employed to provide
individualized feedback to educate participants. In particular, this study tests the use of
collected diary data to educate participants by describing glucose profile information and
presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones throughout the
day, (2) insulin meal bolus information and associated glycemic outcome indices, and (3)
basal rate information with associated glycemic outcome indices.
36 adults with T1DM who already have experience with insulin pump therapy and some
experience with CGM. The study will first track participants for of a 3-day CGM-training
period. The training period will be followed by a 1-week CGM monitoring and CGM data
collection period. Following the 1-week CGM monitoring-only portion of the study,
participants will begin the education intervention component of the study, referred to as
Insight-Based Online Learning Using Simulation and Education for Diabetes (iBOLUSED). The
education intervention component is 4 weeks in length. The intervention will involve daily
diary data upload and daily simulation-based feedback based on the collected diary data.
During the first week (and for up to 2 weeks) of the intervention, participants will view
glycemic outcome data that represents the participant's hypo- and hyperglycemic risk
throughout the day, based on the CGM data collected during the CGM monitoring period. In the
next 2 weeks of the intervention, participants will have an opportunity to interact with the
internet-based system using a simulation-based tool designed to provide insight to the
participant regarding the different effects of modifications to insulin therapy. 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. Two assessments, one prior to the
intervention period and one following the intervention, will be administered to gather
relevant psychobehavioral information. Focus group sessions will be conducted at the end of
the study, which will allow for the collection of information regarding the effectiveness of
the Internet intervention and will provide insight for the design of future studies.
Parallel recording of CGM, insulin, and behavioral data, as well as psychometric
instruments, will produce a rich synchronized data set for each person that will facilitate
the development of personalized behavioral profiles that will be employed to provide
individualized feedback to educate participants. In particular, this study tests the use of
collected diary data to educate participants by describing glucose profile information and
presenting relevant data regarding: (1) hypo- and hyperglycemia risk zones throughout the
day, (2) insulin meal bolus information and associated glycemic outcome indices, and (3)
basal rate information with associated glycemic outcome indices.
Development of an insulin delivery educational tool in T1DM requires fundamental behavioral
and physiology studies, as well as translational modeling and engineering development. In
order to be successful, Closed Loop Control (CLC) in T1DM must adapt to individual
physiologic characteristics and to the behavioral profile of each person. Here, we have laid
the foundation by testing an educational tool that aims at providing feedback to patients
with the goal of optimizing patient's glucose control under conventional insulin therapy.
This educational tool is based on collecting data from patients that are processed by
algorithms giving insight into the relationship between glucose control and psychobehavioral
characteristics of the individual. This information will eventually inform a CLC system,
which will be initialized for each individual based on relevant behavioral and physiologic
characteristics, and will include algorithmic observers of patients' behavior and metabolic
state.
and physiology studies, as well as translational modeling and engineering development. In
order to be successful, Closed Loop Control (CLC) in T1DM must adapt to individual
physiologic characteristics and to the behavioral profile of each person. Here, we have laid
the foundation by testing an educational tool that aims at providing feedback to patients
with the goal of optimizing patient's glucose control under conventional insulin therapy.
This educational tool is based on collecting data from patients that are processed by
algorithms giving insight into the relationship between glucose control and psychobehavioral
characteristics of the individual. This information will eventually inform a CLC system,
which will be initialized for each individual based on relevant behavioral and physiologic
characteristics, and will include algorithmic observers of patients' behavior and metabolic
state.
Inclusion Criteria:
For this pilot trial, recruitment will ONLY occur through UVa's IRB-HSR #14263 Recruitment
Database.
Inclusion criteria for subject to enroll:
1. 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
2. Age 21-65.
3. Use of an insulin pump to treat their diabetes for at least 6 months.
4. Use of a CGM for at least a 6 week period in the past 2 years.
5. Has the ability to use a computer that is capable of running the Dexcom Data Manager
3 software daily.
6. Has regular access to the Internet.
7. Has an identified healthcare provider who can provide advice about diabetes care.
8. Actively using a bolus calculator function with the current insulin pump with
pre-defined parameters for glucose goal, carbohydrate ratio, and insulin sensitivity
factor.
9. 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.
10. Willingness to do extra fingersticks when CGM alarms at low or high end (<70 mg/dl or
>300 mg/dl),
11. Willingness to come to Center for Diabetes Technology on at least two occasions to
obtain and return supplies.
12. Willingness to avoid consumption of acetaminophen-containing products for the
duration of the study.
13. Demonstration of proper mental status and cognition for completion of the study.
14. Has the ability to contact their own personal diabetes care team to have clinical
questions answered about changes to diabetes treatment.
Exclusion Criteria:
1. Individuals with cognitive impairment that prevents understanding either consent form
or intervention content
2. Active renal dialysis
3. Psychiatric disorders that would interfere with study tasks (e.g., substance abuse)
4. History of a systemic deep tissue infection with methicillin-resistant staph aureus
or Candida albicans
5. Known bleeding diathesis or dyscrasia
6. Pregnant or intending to get pregnant during study
7. Active enrollment in another clinical trial
8. Medical requirement for acetaminophen-containing products during the study period for
more than 1 week
9. 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)
10. Individuals who do not have access to their diabetes care team to have clinical
questions answered about changes in their diabetes treatment.
11. Need for MRI/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.
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