Diabetes
Conditions
Brief summary
The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.
Detailed description
This will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accuchek 360 software. All will be capable of independent care of their diabetes. All patients will be 19-65 years of age. The end-points will include similar changes in hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care. There will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.
Interventions
OTHERAccu-Chek 360 software
Study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software.
OTHERNormal care
Control group will receive 5 routine office visits in one year
Sponsors
Hoffmann-La Roche
Columbus Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and Female * 19-65 years of age * Type 1 and 2 diabetes * Computer literate * Independent care of diabetes * Insulin pump allowed (Spirit pump only) * Females on birth control * Can demonstrate competency in the use of the Accuchek Aviva meter, reliability in doing regular home blood sugar determinations
Exclusion criteria
* Creatinine clearance \< 30 cc/min * Severe loss of vision (diabetic retinopathy) * Severe diabetic neuropathy * Known or suspected diabetic gastroparesis * Patients with heart disease * Patients with liver disease * Drug or substantial alcohol use * Use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure * Females that are pregnant or are capable of becoming pregnant * Insulin pump use other than Accucheck Spirit pump
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation. | 18 months |
Countries
United States
Outcome results
None listed