Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1)

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.

DEVICE

Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2)

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.

Trial Locations (1)

22903

University of Virginia, Charlottesville

All Listed Sponsors
lead

Boris Kovatchev, PhD

OTHER

NCT00315939 - Improving Control and Reducing the Risk of Hypoglycemic Episodes in Type 1 Diabetes | Biotech Hunter | Biotech Hunter