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
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 18, 2006
CompletedFirst Posted
Study publicly available on registry
April 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
September 9, 2014
CompletedSeptember 18, 2014
August 1, 2014
3.9 years
April 18, 2006
August 8, 2014
September 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
Group A Order: SMBG, IBMF-1, IBMF-2
EXPERIMENTALGroup 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.
Group B Order: IBMF-1, IBMF-2, SMBG
EXPERIMENTALGroup 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22903, United States
Related Publications (1)
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.
PMID: 21216860BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boris Kovatchev, PhD
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Boris Kovatchev, Ph.D.
University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 18, 2006
First Posted
April 19, 2006
Study Start
January 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
September 18, 2014
Results First Posted
September 9, 2014
Record last verified: 2014-08