N/A
Completed N=120
E-health Care Process Support for Diabetes Type II Patients
Diabetes Mellitus Type II,
Source: ClinicalTrials.gov NCT01566981 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in HbA1C at 1 Year. — 0.6925; 0.1707 percentage of glycated haemoglobin — p=0.005
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1C at 1 Year. |
0.6925; 0.1707 | 0.005 sig |
| SECONDARY Body Mass Index at 1 Year |
31.76; 32.6 | — |
| SECONDARY Patients' Functional Health Status Via WONCA-COOP Questionnaire. |
2.12; 1.89 | — |
| SECONDARY Change of Blood Lipid Level ( Low Density Cholesterol) |
— | — |
| SECONDARY Quality of Patients' Life Via WONCA-COOP Questionnaire. |
— | — |
| SECONDARY Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire. |
— | — |
| SECONDARY Change of the Following Parameter : HbA1C |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01566981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.