N/A N=120 Randomized

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

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT00315939 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Hemoglobin A1c — 7.99; 7.69; 7.69; 7.58 percentage of glycated hemoglobin — p==0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) (Device); Integrated Biobehavioral Monitoring & Feedback - 2 (IBMF-2) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Boris Kovatchev, PhD
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemoglobin A1c	7.99; 7.69; 7.69; 7.58	=0.001 sig
PRIMARY Frequency of Severe Hypoglycemia	0.09; 0.21; 0.15; 0.02	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00315939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.