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Improved Glycemic Control in Adult Subjects With Type 1 Diabetes on MDI Using Insulin Guidance Software

NCT00552734 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2015-08-13

No results posted yet for this study

Summary

140 subjects will be enrolled into the clinical study and randomized into the Control Group or the Experimental Group by block randomization. The subjects must meet all inclusion and none of the exclusion criteria. Each subject will have 7 clinic visits and 3 phone visits. The Baseline Visit will consist of a complete history, vitals, a physical examination and completion of the consent and screening process. All clinic visits, except for the Baseline Visit will include meter/PDA download. In addition, meter education will be provided to all subjects, and PDA education will be provided to the Experimental group at the Baseline Visit and 2-Week Visit as needed to ensure subject understanding. The phone visits will consist of a history including any changes in insulin dose, and any hypoglycemic events, hyperglycemic events, or other adverse events that have occurred since the last clinic visit.

The primary endpoint in this study was to show a reduction in A1c of at least 0.4% or higher in the insulin guidance software group at 6 months and/or 1 year.

Conditions

Interventions

DEVICE

Insulin Guidance Software

At baseline a healthcare provider reviewed the features of the software on the PDA and loaded a subject specific insulin dosing algorithm into the software based on the physician's recommendations. The program advised basal, bolus and correction insulin dosages based on individual patients' prescriptions in addition to being alerted for SMBG testing. Subjects in the experimental group were also asked to input their blood glucose values into the PDA via the touch screen. Subjects then received a recommended insulin dose based on their prescription which was programmed by the healthcare provider. The patients were asked to either agree with the recommended insulin dose or disagree, and manually enter the insulin dose they took for a given event.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Satish K Garg, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00552734 on ClinicalTrials.gov