A German Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Type 2 Diabetes Patients. (PDM-ProValueGP)

November 22, 2017 updated by: Hoffmann-La Roche

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 General Medical Practices in Germany (GP).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

414

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Albstadt, Germany, 72461
      • Auerbach/Vogtland, Germany, 08209
      • Bad Kreuznach, Germany, 55545
      • Beucha, Germany, 04824
      • Beutel/Templin, Germany, 17268
      • Blankenhain, Germany, 99444
      • Bochum, Germany, 44805
      • Bockenem, Germany, 31167
      • Borna, Germany, 04552
      • Bremerhaven, Germany, 27572
      • Cloppenburg, Germany, 49661
      • Dransfeld, Germany, 37127
      • Dresden, Germany, 01309
      • Düren, Germany, 52349
      • Elsterwerda, Germany, 04910
      • Essen, Germany, 45355
      • Essen, Germany, 45359
      • Essen, Germany, 45329
      • Föhren, Germany, 54343
      • Geringswalde, Germany, 09326
      • Giessen, Germany, 35390
      • Hannover, Germany, 30163
      • Hemsbach, Germany, 69502
      • Herborn, Germany, 35745
      • Kerpen, Germany, 50169
      • Krefeld, Germany, 47803
      • Kreuzau, Germany, 52372
      • Köthen, Germany, 06366
      • Leipzig, Germany, 04315
      • Loehne, Germany, 32584
      • Lübeck, Germany, 23562
      • Mainz, Germany, 55116
      • Mainz, Germany, 55130
      • Meissen, Germany, 01662
      • Meudt, Germany, 56414
      • Papenburg, Germany, 26871
      • Reinfeld, Germany, 23858
      • Riesa, Germany, 01589
      • Rochlitz, Germany, 09328
      • Rodgau, Germany, 63110
      • Schleiden, Germany, 53937
      • Schwedt, Germany, 16303
      • Schweich, Germany, 54338
      • Schweich, Germany, 54343
      • Siegen, Germany, 57072
      • Sigmaringen, Germany, 72488
      • Staufenberg, Germany, 35460
      • Trier, Germany, 54290
      • Weida, Germany, 07570
      • Wetzlar, Germany, 35584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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% within the last 6 weeks before study visit 1 (patient's inclusion)
  • Longer-term diabetes care by the trial site (at least for the duration of the 12-month study participation)
  • General practitioner is the primary practitioner in the diabetes care of the patient
  • 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:

  • Diabetes treatment by insulin pump therapy (CSII)
  • Experience with the use of special software for systematic processing of SMBG data, e.g. the Accu-Chek® Smart Pix System/Software, the Accu-Chek® 360° Software and/or the Diabetes Software DIABASS
  • 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, drug 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
Patients treated by usual customary medical practice (Usual Care)
Device: Accu-Chek Smart Pix readout Device
Smartpix device for data upload out from blood glucose meter devices
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean HbA1c change by Generalized Estimating Equations (GEE) methods
Time Frame: from Baseline to 12 months
from Baseline to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Roche Diabetes Care Deutschland GmbH

Investigators

  • Study Director: Iris Vesper, Roche Diabetes Care Deutschland GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2014

Primary Completion (Actual)

January 11, 2017

Study Completion (Actual)

February 9, 2017

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD001231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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