Trial Information

Summary: A Study of Accu-Chek Advisor Insulin Guidance Software in Adolescents and Young Adults With Type 1 Diabetes Mellitus.

Status: Completed

Protocol Number: 2005-09

Sponsor: Roche Diagnostics

Company Division: Diagnostic

Official Scientific Title:

Brief Summary: This study compares the standard of care to standard of care plus the use of Accu-Chek Advisor Insulin Guidance Software for personal data assistants in adolescents and young adults diagnosed with Type 1 diabetes. Clinic visits are scheduled every 3 months. The anticipated duration of the trial is 12 months, and the target sample size is 160 individuals.

Study Phase: N/A

Study Design / Study Details:

  • Purpose:
  • Allocation:
  • Masking:
  • Control:
  • Assignment:
  • Endpoints:

Study Type:

Interventional

Condition: Diabetes Mellitus, Type 1

Intervention Type: Diagnostic Test

Intervention Name: Accu-Chek Advisor Insulin Guidance Software

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

  • male or female subjects, 12–21 years of age;
  • Type 1 diabetes for ≥1 year before enrollment;
  • HbA1c ≥7.5% and <=12%;
  • dual-insulin regimen (≥2 daily injections) supported by Accu-Chek Advisor software;
  • weight between 100 and 300 pounds;
  • agreement to perform ≥3 pre-meal capillary blood glucose testing per day.

Exclusion Criteria:

  • continuous subcutaneous insulin infusion therapy (insulin pump);
  • insulin regimen not supported by Accu-Chek Advisor software;
  • any condition that may cause significant increase of insulin sensitivity factor (eg, need for corticosteroid therapy, diabetic ketosis, or insulin-resistant syndrome);
  • pregnancy;
  • other chronic disease such as cancer and renal failure;
  • major phsychological disturbance.

Gender: Males or Females

Age Limits: Min: Years

Accepts Healthy Volunteers: No

Anticipated Start Date: August, 2005

Trial Registration Date: 08/08/2005

Date Last Updated: 12/18/2007

Link To Trial Results

Contact:

Research Site:
Located In:
Indianapolis, IN
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: October 6, 2008 at 2:33:49 PM


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