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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hoffmann-La Roche
Roche Diagnostics Deutschland GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 3, 2014
Last updated: February 23, 2015
Last verified: March 2014

This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-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)

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: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 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)


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

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 identifier: NCT02156349

Contact: Bernhard Kulzer +49 7931 /594-151

Altenstadt, Germany, 63674
Bad Mergentheim, Germany, 97980
Bad Sackingen, Germany, 79713
Buxtehude, Germany, 21614
Cuxhaven, Germany, 27474
Dinslaken, Germany, 46537
Düsseldorf, Germany, 40211
Essen, Germany, 45329
Frankfurt a.M., Germany, 60326
Fulda, Germany, 36039
Fulda, Germany, 36037
Gelnhausen, Germany, 63571
Gummersbach, Germany, 51645
Göttingen, Germany, 37073
Hamburg, Germany, 22119
Hamburg, Germany, 21109
Hanau, Germany, 63450
Hannover, Germany, 30165
Immenhausen, Germany, 34376
Kassel, Germany, 34117
Köln-Weiden, Germany, 50858
Lampertheim, Germany, 68623
Laupheim, Germany, 88471
Lingen (Ems), Germany, 49808
Offenbach, Germany, 63065
Pirna, Germany, 1796
Porta Westfalica, Germany, 32457
Rehburg-Loccum, Germany, 31547
Rüsselsheim, Germany, 65428
Villingen-Schwenningen, Germany, 78054
Wiesbaden, Germany, 65183
Zierenberg, Germany, 34289
Sponsors and Collaborators
Hoffmann-La Roche
Roche Diagnostics Deutschland GmbH
Study Director: Iris Vesper Roche Diagnostics Deutschland GmbH
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT02156349     History of Changes
Other Study ID Numbers: RD001732
Study First Received: June 3, 2014
Last Updated: February 23, 2015
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on March 01, 2015