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Therapeutic Areas: Endocrinology
Disease Category: Diabetes Mellitus, Type 1
Trial Information
A Study of Accu-Chek Advisor Insulin Guidance Software for Maintaining Glycemic Control and Preventing Hypoglycemia in Intensively Treated Patients with Type 1 Diabetes
Status: Completed
Protocol Number: 2004-08
Sponsor: Roche Diagnostics
Company Division: Diagnostic
Official Scientific Title:
Brief Summary: This study will evaluate the effect of the Accu-Chek Advisor Insulin Guidance Software program for personal data assistants (PDAs), compared with the standard of care, in patients diagnosed with Type 1 diabetes on multiple daily insulin injections.
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:
• adult patients 18–60 years of age;
• diagnosis of Type 1 diabetes mellitus for >=6 months;
• insulin dose 0.5–2.0 U/kg;
• weight 100–300 pounds;
• dual insulin therapy supported by Accu-Chek Insulin Advisor software
• willing to perform >=3 blood glucose tests/day
• HbA1c > 7.5% and < 11.0%
Exclusion Criteria:
• insulin pump therapy;
• oral, inhaled, or pre-mixed insulin;
• 30 minutes of cardiovascular (aerobic) exercise 5 days of a 7-day week.
• renal insufficiency
• on a day shift schedule (this is a limitation of the Accu-Chek Advisor software)
• renal insufficiency
• diagnosis of liver disease, hepatitis, hemoglobinopathy
• pregnant or intends to become pregnant
• severe hypoglycemia requiring Emergency Department admission
Gender: Males or Females
Age Limits: Min: Years
Accepts Healthy Volunteers: No
Trial Registration Date: 06/24/2005
Date Last Updated: 04/17/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located in:
Aurora, CO 80010
Phone: 888-662-6728 (U.S. Only)
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