MedTrace Logo

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

NCT00315939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-09-18

Study results available
· View outcomes & findings →

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.

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.

Sponsors & Collaborators

  • Boris Kovatchev, PhD

    lead OTHER

Principal Investigators

  • Boris Kovatchev, Ph.D. · University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00315939 on ClinicalTrials.gov