This trial is active, not recruiting.

Condition diabetes mellitus type 2
Treatments self-monitoring for patients with diabetes mellitus type 2, nurse-monitoring for patients with diabetes mellitus type 2
Sponsor Landeskrankenanstalten-Betriebsgesellschaft
Collaborator European Commission
Start date February 2010
End date June 2013
Trial size 194 participants
Trial identifier NCT01580098, D250487


Evaluation whether the introduction of large-scale personalized and technology supported telemonitoring and health coaching interventions produces benefits in terms of health related quality of life, health status and empowerment of patients with type 2 diabetes mellitus. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(No Intervention)
treatment as usual
Patients are self-monitoring and submitting their vital parameters.
self-monitoring for patients with diabetes mellitus type 2
Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
Nurses are measuring and entering the vital parameters of the patients.
nurse-monitoring for patients with diabetes mellitus type 2
Nurses are submitting the vital parameters of the patient via mobile device.

Primary Outcomes

Health related quality of life as measured by the SF 36 version 2 questionnaire
time frame: 12 months
time frame: 12 months

Secondary Outcomes

Blood pressure
time frame: 12 months
Blood lipids
time frame: 12 months
Body weight
time frame: 12 months
Medication changes
time frame: 12 months
Presence of diabetic complications
time frame: 12 months
Number of hospitalisations
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - T2DM diagnosed > 3 months prior to the enrollment - HbA1c >= 6,5 % - Capability of filling questionnaires by their own language - Being able to use the devices provided - Being cognitively able to participate Exclusion Criteria:

Additional Information

Official title Regions of Europe Working Together for Health (Renewing Health)
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Landeskrankenanstalten-Betriebsgesellschaft.