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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02156349
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : November 14, 2017
Roche Diabetes Care Deutschland GmbH
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Type II Diabetes Mellitus Device: Accu-Chek Smart Pix Software Device: Accu-Chek Smart Pix readout Device Not Applicable

Detailed Description:
Outcome of both studies (RD001732 and RD001231) will be integrated and additionally reported as PDM-ProValue study program (Integrated Personalized Diabetes Management) due to the high similarity in study characteristics, design and study results.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : May 14, 2014
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Control Group
Patients treated by usual customary medical practice (Usual Care) in the out-patient facility i.e. Diabetes specialized medical practice, Medical Care Center or hospital outpatient clinic.
Device: Accu-Chek Smart Pix readout Device
Smartpix device for data upload out of blood glucose meter devices

Intervention group
Patients are treated according to the concept "Integrated personalized diabetes management".
Device: Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)

Primary Outcome Measures :
  1. The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods [ Time Frame: from Baseline to 12 months ]
    The difference in the HbA1c change after 12 months between the Intervention group and the Control group is analyzed by means of generalized estimating equations (Generalized Estimating Equations [GEE]) methods (population averaged model) and here, robust assessors (so-called sandwich assessors) for the standard errors are provided. The dependent variable is the HbA1c change after 12 months, while the HbA1c baseline considers the gender and the age as factors of influence (covariates) in the GEE model.

Secondary Outcome Measures :
  1. Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 except Basal Cell Carcinoma) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02156349

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Sponsors and Collaborators
Hoffmann-La Roche
Roche Diabetes Care Deutschland GmbH
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Study Director: Iris Vesper Roche Diabetes Care Deutschland GmbH
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Responsible Party: Hoffmann-La Roche Identifier: NCT02156349    
Other Study ID Numbers: RD001732
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by Hoffmann-La Roche:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases