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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Diabetes Care Deutschland GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02156349
First received: June 3, 2014
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
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
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 Integrated PDM in the Care of People With Type 2 Diabetes 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 ]

Enrollment: 558
Study Start Date: May 2014
Estimated Study Completion Date: April 2017
Primary Completion Date: June 2015 (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 blood 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • existence of a signed Informed Consent form (before any study procedure)
  • diagnosed Type 2 diabetes mellitus
  • age ≥18 years
  • insulin therapy for ≥6 months: BOT, SIT, CT or ICT
  • HbA1c ≥7.5% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days 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 compulsory member 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:

  • Treatment of diabetes with insulin pump (CSII)
  • Methodic and continuous with the use of particular software for processing of SMBG data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (eGFR < 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye)
  • Existing tumor illness (primary tumor/local recurrence/ metastases) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). Exception: Basal Cell Carcinoma Within a tumor free time of < 5 years Medical Affairs will decide about individual cases
  • permanent 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
  • dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member
  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

Locations
Germany
Altenstadt, Germany, 63674
Augsburg, Germany, 86179
Bad Mergentheim, Germany, 97980
Bad Sackingen, Germany, 79713
Berlin, Germany, 01627
Berlin, Germany, 13597
Birkenfeld, Germany, 55624
Bitburg, Germany, 54634
Buxtehude, Germany, 21614
Cuxhaven, Germany, 27474
Dresden, Germany, 01219
Dresden, Germany, 01307
Essen, Germany, 45329
Frankfurt am Main, Germany, 60326
Fulda, Germany, 36039
Gelnhausen, Germany, 63571
Giessen, Germany, 35390
Gottingen, Germany, 37073
Gummersbach, Germany, 51645
Hamburg, Germany, 21109
Hamburg, Germany, 22119
Hanau, Germany, 63450
Hannover, Germany, 30171
Herne, Germany, 44653
Hessen, Germany, 36037
Immenhausen, Germany, 34376
Jena, Germany, 07743
Kassel, Germany, 34117
Koln, Germany, 50858
Lauf (Pegnitz), Germany, 91207
Laupheim, Germany, 88471
Lingen, Germany, 49808
Neustadt am Rübenberge, Germany, 31535
Nordrhein-Westfalen, Germany, 40211
Nordrhein-Westfalen, Germany, 46537
Offenbach, Germany, 63065
Oranienburg, Germany, 16515
Pirna, Germany, 1796
Porta Westfalica, Germany, 32457
Rehburg-Loccum, Germany, 31547
Russelsheim, Germany, 65428
Schweinfurt, Germany, 97421
Sulzbach-Rosenberg, Germany, 92237
Trier, Germany, 54290
Villingen-Schwenningen, Germany, 78054
Wiesbaden, Germany, 65183
Zierenberg, Germany, 34289
Zossen, Germany, 15806
Sponsors and Collaborators
Hoffmann-La Roche
Roche Diabetes Care Deutschland GmbH
Investigators
Study Director: Iris Vesper Roche Diabetes Care Deutschland GmbH
  More Information

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: June 30, 2016
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

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

ClinicalTrials.gov processed this record on August 30, 2016