- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315939
Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes (BPK002)
Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- Have type 1 diabetes as defined by the American Diabetes Association or by the judgment of the physician
- Willing to participate for up to one year
- Perform routine blood glucose checks 3-4 times a day
- Complete monthly diaries of the occurrence of severe and moderate hypoglycemic episodes
- Have 6 hemoglobin A1c (HgbA1c) drawn
- Have a mixed meal tolerance test to assess for residual pancreatic insulin secretion
Exclusion Criteria:
- Age < 18 years
- Currently abusing alcohol or drugs
- Severe depression or psychosis
- Significant mental impairment
- Inability to use a glucometer and a hand held computer
- Pregnant or desire to achieve pregnancy within the following year (females)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A Order: SMBG, IBMF-1, IBMF-2
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.
|
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.
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.
|
Experimental: Group B Order: IBMF-1, IBMF-2, SMBG
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c
Time Frame: 1 year (each level lasted 3 months)
|
1 year (each level lasted 3 months)
|
|
Frequency of Severe Hypoglycemia
Time Frame: 1 year (each level lasted 3 months)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Boris Kovatchev, Ph.D., University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
Publications and helpful links
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
- 12126
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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