A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Hoffmann-La Roche
Sponsor:
Collaborator:
Roche Diagnostics Deutschland GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02156349
First received: June 3, 2014
Last updated: August 26, 2014
Last verified: March 2014
  Purpose

This study is a German, prospective, multicenter, controlled, cluster-randomized

, interventional comparative study evaluating the efficacy and benefits of integ rated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patie nts will be randomized into two groups to use Accu-Chek Smartpix software and Ac cu-Chek Smartpix device.


Condition Intervention
Diabetes Mellitus Type 2
Device: Accu-Chek Smart Pix Software
Device: Accu-Chek Smart Pix readout Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Integrated Personalized Diabetes Management (Integrated PDM): Prospective, Randomized, Controlled Intervention Study for the Evaluation of the Effectiveness and the Benefit of Intergrated PDM in the Care of People With Type 2 Diabates in Diabetes Specialized Medical Practices in Germany (DSP)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • The mean HbA1c change by means of Generalized Estimating Equations [GEE] methods [ Time Frame: from Baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Group
Patients treated by usual customary medical practice (Usual Care)
Device: Accu-Chek Smart Pix readout Device
Smartpix device for data upload out of bloog glucose meter devices
Intervention group
Patients treated with "Integrated personalized diabetes management"
Device: Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Existence of a signed Informed Consent form
  • Diagnosed Type 2 Diabetes mellitus
  • Age > / =18 years
  • Insulin therapy for >/ =6 months: Basal-supported Oral Therapy (BOT), Supplementary Insulin Therapy (SIT), Conventional Insulin Therapy (CT) or Intensified Therapy (ICT)
  • HbA1c > / =7.5% within the last 6 weeks before study visit 1 (patient's inclusion)
  • Longer-term care (at least for the duration of the 12-month study participation) by the trial site
  • Insured by the statutory health insurance (GKV) as a statutory or voluntarily insured member or as a family co-insured member
  • Willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the German language, spoken and written

Exclusion Criteria:

  • Experience with structured SMBG with the use of data processing systems / software e.g. the Accu-Chek ® Smart Pix system and/or the Accu-Chek ® 360° diabetes management software
  • Presence of terminal renal failure / dialysis and/or a loss of sight or a tumor illness
  • Chronic use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy
  • Known alcohol and drug abuse and medication abuse
  • Known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement)
  • Existing pregnancy, breast-feeding or plan to become pregnant during study participation
  • Physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02156349

Contacts
Contact: Bernhard Kulzer +49 7931 /594-151 kulzer@diabetes-zentrum.de

Locations
Germany
Not yet recruiting
Bad Mergentheim, Germany, 97980
Not yet recruiting
Buxtehude, Germany, 21614
Not yet recruiting
Hamburg, Germany, 21109
Not yet recruiting
Kassel, Germany, 34117
Not yet recruiting
Lampertheim, Germany, 68623
Sponsors and Collaborators
Hoffmann-La Roche
Roche Diagnostics Deutschland GmbH
Investigators
Study Director: Iris Vesper Roche Diagnostics Deutschland GmbH
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02156349     History of Changes
Other Study ID Numbers: RD001732
Study First Received: June 3, 2014
Last Updated: August 26, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014