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NCT Number: NCT01566981

E-health Care Process Support for Diabetes Type II Patients

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.

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Key information

Conditions

Diabetes Mellitus Type II, Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Family medicine, Medical Faculty, Ljubljana, Slovenia

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About this study

Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2 DM accounts for 90% to 95% of all diabetes cases.

Results of many clinical studies demonstrated the great potential of information and communication technology (ICT) applications to improve health care of patients with chronic diseases including diabetes mellitus.

In this study an ICT mobile environment to improve the process of an integrated care of people with Diabetes mellitus will be identified, developed, introduced and clinically evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who are managed in primary care. The study will use and evaluation questionnaire that will cover issues regarding the patient quality of life.

Subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight.

Subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. In addition to this, users can enter values about their physical activity (type, duration, intensity).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerised support to the Diabetes type II patients

Procedure

The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.

Other names: eDiabetes in Primary healthcare

Primary outcomes

  1. Change From Baseline in HbA1C at 1 Year.

    Time frame: 1 year

Secondary outcomes

  1. Body Mass Index at 1 Year

    Time frame: one year

  2. Patients' Functional Health Status Via WONCA-COOP Questionnaire.

    Time frame: one year

    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.

  3. Change of Blood Lipid Level ( Low Density Cholesterol)

    Time frame: baseline and one year

  4. Quality of Patients' Life Via WONCA-COOP Questionnaire.

    Time frame: baseline and one year

  5. Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.

    Time frame: baseline and one year

  6. Change of Blood Lipid Level ( Low Density Cholesterol)

    Time frame: baseline and six months

  7. Change of the Following Parameter : HbA1C

    Time frame: baseline and six months

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Collaborators

  • University of Ljubljana School of Medicine, Slovenia

Registry information

Official study title

E-support for Healthcare Processes - DIABETES

Acronym: EHDI

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2012
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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