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The purpose of this study is to test two newly developed computer programs, Integrated Biobehavioral Monitoring and Feedback (IBMF) IBMF-1 and IBMF-2. The computer programs are considered experimental. Both computer programs are being tested to see if they are useful in helping people with type 1 diabetes avoid low blood sugar episodes.
Subjects were randomized into group A or group B matched by gender, age, and baseline HbA1c. Group A began with routine self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by IBMF-1 (level 2) and IBMF-2 (level 3). Group B began with level 2, followed by level 3 and then level 1.
Each level continued for 3 months and proceeded as follows: level 1 was routine SMBG. Subjects were given LifeScan OneTouch UltraSmart meters (LifeScan Inc., Milpitas, CA) and free strips, and asked to perform SMBG four to five times per day. No additional instructions about the timing of SMBG or the interpretation of the data were given. No changes to treatment were recommended. At each visit, the subject was only asked about any health concerns or any new medications or change in insulin. This information was recorded but not used for feedback. Thus, level 1 should be regarded as a control condition, which was different from routine SMBG only because subjects were enrolled in a study and given free test strips.
IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index, LBGI), and glucose variability (Average Daily Risk Range, ADRR) using previously published algorithms. The subjects were asked to carry the HHC and enter all their glucose readings when per- forming SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions.
IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Order: SMBG, IBMF-1, IBMF-2 | Experimental | Group A performed routine self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) level 3. Each level continued for 3 months. |
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| Group B Order: IBMF-1, IBMF-2, SMBG | Experimental | Group B began with Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2, followed by level 3, Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) and then level 1 (SMBG only). Each level continued for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) | Device | Integrated Biobehavioral Monitoring & Feedback-1 (IBMF-1): a hand-held computer (HHC) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia (Low BG Index), and glucose variability (Average Daily Risk Range) using previously published algorithms. The subjects were asked to carry the HHC and enter all their self-monitored blood glucose (SMBG) readings. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. Detailed instructions were provided on the meaning of these different types of glucose feedback; the study staff was available to answer any questions. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | 1 year (each level lasted 3 months) | |
| Frequency of Severe Hypoglycemia | Severe hypoglycemia (SH) was defined to subjects as "blood glucose so low that you could not treat yourself because you were stuporous or unconscious." | 1 year (each level lasted 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Kovatchev, Ph.D. | University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21216860 | Background | Kovatchev BP, Mendosa P, Anderson S, Hawley JS, Ritterband LM, Gonder-Frederick L. Effect of automated bio-behavioral feedback on the control of type 1 diabetes. Diabetes Care. 2011 Feb;34(2):302-7. doi: 10.2337/dc10-1366. Epub 2011 Jan 7. |
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A total of 120 adults with type 1 diabetes were recruited through regional advertising. Inclusion criteria were age ≥18 years, type 1 diabetes defined by the American Diabetes Association criteria or physician judgment, and willingness to participate in the study for up to 12 months performing finger sticks four to five times per day.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 | Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. |
| FG001 | Experimental: Group B Order: IBMF-1, IBMF-2, SMBG | Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Admission 1 (3 Months) |
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| Admission 2 (3 Months) |
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| Admission 3 (3 Months) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Group A Order: SMBG, IBMF-1, IBMF-2 | Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months. |
| BG001 | Experimental: Group B Order: IBMF-1, IBMF-2, SMBG |
| 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 | Hemoglobin A1c | All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using "dropout" as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 1 year (each level lasted 3 months) |
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January 2006 - December 2009
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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 | IBMF-1 | IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Kovatchev, PhD | University of Virginia | 434-924-5592 | bpk2u@virginia.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) | Device | Integrated Biobehavioral Monitoring & Feedback-2 (IMBF-2) retains IMBF-1, but the HHC asked subjects to provide symptom ratings when blood glucose (BG) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. The patient manual for the HHC program is provided in supplementary data of published manuscript. |
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Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Frequency of Severe Hypoglycemia | Severe hypoglycemia (SH) was defined to subjects as "blood glucose so low that you could not treat yourself because you were stuporous or unconscious." | All 120 participants were analyzed; data for subjects who dropped out during the study were handled according to the intention-to-treat principle, using "dropout" as a factor and adjusting significance levels accordingly. Below data for the 97 participants who completed the 1-year protocol are shown. | Posted | Number | episodes/month/person | 1 year (each level lasted 3 months) |
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| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | IBMF-2 | IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure. | 0 | 107 | 0 | 107 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
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| SH Post-Level 3 |
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