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Sponsored by: |
University of Colorado at Denver and Health Sciences Center |
Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00552734 |
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.
Condition | Intervention |
Diabetes |
Device: Insulin Guidance Software |
MedlinePlus related topics: | Diabetes Diabetes Type 1 |
ChemIDplus related topics: | Insulin Dextrose BaseLine Proparacaine Proparacaine hydrochloride |
Study Type: | Observational |
Study Design: | Other, Prospective |
Official Title: | Glycemic Control and Prevention of Hypoglycemia in Intensively Treated Subjects With Type 1 Diabetes Using Accu-Chek® Advisor Insulin Guidance Software |
Enrollment: | 123 |
Study Start Date: | July 2005 |
Study Completion Date: | May 2007 |
Groups/Cohorts | Assigned Interventions |
Control
The other half of the patients were randomized to the control group who were followed for their routine diabetes care and had to visit the clinic on the same schedule as the experimental group.
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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.
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Experimental
Half of the subjects were randomized to this group using insulin guidance software on a PDA to adjust their insulin dose at home based on the prescription provided by the provider.
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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.
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
123 adult subjects ages 18-60 with type 1 diabetes on mulitiple daily injections
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |||||
University of Colorado Health Sciences Center, Barbara Davis Center for Diabetes | |||||
Aurora, Colorado, United States, 80045 |
University of Colorado at Denver and Health Sciences Center |
Principal Investigator: | Satish K Garg, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | COMIRB Protocol # 04-0834 |
First Received: | October 31, 2007 |
Last Updated: | November 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00552734 |
Health Authority: | United States: Institutional Review Board |
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