At a glance
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Improving Metabolic Control and Reducing Hypoglycemic Risk in Type 1 Diabetes Mellitus With Biological and Behavioral Feedback
In Brief
A clinical study evaluating Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) and Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) for Diabetes Mellitus, Type 1. Completed, enrolled 120 participants across 1 site.
Detailed 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.
Study Details
Timeline
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.