NCT01566981

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 29, 2014

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

February 12, 2012

Results QC Date

July 27, 2014

Last Update Submit

October 28, 2014

Conditions

Diabetes Mellitus Type II,

Keywords

Diabetes mellitus tip IIeHealth solutionHealth Information Technologyquality of lifefamily medicinesatisfaction with e-health careprimary care

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in HbA1C at 1 Year.

    1 year

Secondary Outcomes (7)

  • Body Mass Index at 1 Year

    one year

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

    one year

  • Change of Blood Lipid Level ( Low Density Cholesterol)

    baseline and one year

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

    baseline and one year

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

    baseline and one year

  • +2 more secondary outcomes

Study Arms (2)

Diabetes with ICT support (E-diabetes)

EXPERIMENTAL

The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients

Procedure: Computerised support to the Diabetes type II patients

Diabetes without support

NO INTERVENTION

The group of randomly selected patients with DM type II, without software application and web-based support.

Interventions

Computerised support to the Diabetes type II patientsPROCEDURE

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

Also known as: eDiabetes in Primary healthcare
Diabetes with ICT support (E-diabetes)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • significant co-morbidity
  • Type 1 diabetes
  • Insulin-dependent type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of family medicine in Ljubljana

Ljubljana, 1000, Slovenia

Location

Department of Family medicine, Medical Faculty

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr. Rade Iljaž
Organization
Department of family medicine, Medical Faculty in Ljubljana
radeiljaz@gmail.com
'386 31 300- 381

Study Officials

  • Andrej Brodnik, PhD

    University of Ljubljana, FRI and University of Primorska, DIST

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2012

First Posted

March 30, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 29, 2014

Results First Posted

October 29, 2014

Record last verified: 2014-10

Locations

SL(2)