Diabetes Mellitus Type II, Clinical Trial
— EHDIOfficial title:
E-support for Healthcare Processes - DIABETES
Verified date | October 2014 |
Source | University of Primorska |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Ethics Committee |
Study type | Interventional |
The purpose of the study is to clinically evaluate a new approach to treatment of patients
with diabetes mellitus type II by using specially developed mobile-internet software
solution.
The effect of information and communication technologies (ICT) to improve the integrated
care of people with diabetes will be identified, developed, introduced and clinically
evaluated.
The investigators expect that usage of an e-Health application in health care of patients
with diabetes mellitus type II could improve the following healthcare outcomes: results of
the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood
pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Type 2 diabetes, treated with non-pharmacological interventions or/and tablets (Non-Insulin-Dependent Diabetes Mellitus) - Internet connection and personal computer /lap-top computer - Mobile phone - Sufficient level of Internet and e-mail usage - checked by short questionnaire - Age >18 or <75 years Exclusion Criteria: - significant co-morbidity - Type 1 diabetes - Insulin-dependent type 2 diabetes |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Slovenia | Department of family medicine in Ljubljana | Ljubljana | |
Slovenia | Department of Family medicine, Medical Faculty | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University of Primorska | University of Ljubljana School of Medicine, Slovenia |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in HbA1C at 1 Year. | 1 year | No | |
Secondary | Body Mass Index at 1 Year | one year | No | |
Secondary | Patients' Functional Health Status Via WONCA-COOP Questionnaire. | WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score. | one year | No |
Secondary | Change of Blood Lipid Level ( Low Density Cholesterol) | baseline and one year | No | |
Secondary | Quality of Patients' Life Via WONCA-COOP Questionnaire. | baseline and one year | No | |
Secondary | Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. | baseline and one year | No | |
Secondary | Change of Blood Lipid Level ( Low Density Cholesterol) | baseline and six months | No | |
Secondary | Change of the Following Parameter : HbA1C | baseline and six months | No |