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

November 13, 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 Diabetes Specialized Medical Practices in Germany (DSP)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
558

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Altenstadt, Germany, 63674
        • Private Practice
      • Augsburg, Germany, 86179
        • Internistische Gemeinschaftspraxis
      • Bad Mergentheim, Germany, 97980
        • Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)
      • Bad Sackingen, Germany, 79713
        • Private Practice
      • Berlin, Germany, 01627
        • Private Practice
      • Berlin, Germany, 13597
        • Mvz am Bahnhof Spandau
      • Bitburg, Germany, 54634
        • Gemeinschaftspraxis
      • Buxtehude, Germany, 21614
        • Private Practice
      • Cuxhaven, Germany, 27474
        • Private Practice
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
      • Dresden, Germany, 01219
        • Diabetologicum Dresden
      • Dusseldorf, Germany, 40212
        • Gemeinschaftspraxis Schaden
      • Essen, Germany, 45329
        • Private Practice
      • Falkensee, Germany, 14612
        • Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
      • Frankfurt am Main, Germany, 60326
        • Private Practice
      • Fulda, Germany, 36039
        • Gemeinschaftspraxis
      • Gelnhausen, Germany, 63571
        • Private Practice
      • Giessen, Germany, 35390
        • Hausärztliche internistische Gemeinschaftspraxis Giessen
      • Gottingen, Germany, 37073
        • Diabetes- und Gesundheitszentrum Göttingen
      • Gummersbach, Germany, 51645
        • Private Practice
      • Hamburg, Germany, 21109
        • Private Practice
      • Hamburg, Germany, 22119
        • Diabeteszentrum
      • Hanau, Germany, 63450
        • Private Practice
      • Hannover, Germany, 30159
        • Integriertes Diabetiker-Zentrum Hannover
      • Herne, Germany, 44653
        • Gemeinschaftspraxis
      • Hessen, Germany, 36037
        • Gemeinschaftspraxis im Altstadt-Carree
      • Immenhausen, Germany, 34376
        • Private Practice
      • Jena, Germany, 07743
        • Universitätsklinikum Jena, Klinik für Innere Medizin III
      • Kassel, Germany, 34117
        • Diabeteszentrum Kassel
      • Koln, Germany, 50858
        • Praxis Kugler
      • Lampertheim, Germany, 68623
        • Internistische Praxis Lampertheim
      • Lauf (Pegnitz), Germany, 91207
        • Private Practice
      • Laupheim, Germany, 88471
        • Private Practice
      • Lingen, Germany, 49808
        • Private Practice
      • Neustadt am Rübenberge, Germany, 31535
        • Diabetes-Zentrum Neustadt
      • Nordrhein-Westfalen, Germany, 46537
        • Diabetologische Schwerpunktpraxis
      • Offenbach, Germany, 63065
        • Private Practice
      • Oranienburg, Germany, 16515
        • Diabetes Praxis Oranienburg
      • Pirna, Germany, 01796
        • Arztpraxis fur Allg-Med
      • Porta Westfalica, Germany, 32457
        • Private Practice
      • Rehburg-Loccum, Germany, 31547
        • Private Practice
      • Rhaunen, Germany, 55624
        • Gemeinschaftspraxis
      • Russelsheim, Germany, 65428
        • Pivate Practice
      • Schweinfurt, Germany, 97421
        • Ambulanzzentrum Schweinfurt
      • Sulzbach-Rosenberg, Germany, 92237
        • Versdias GmbH
      • Trier, Germany, 54292
        • Private Practice
      • Villingen-Schwenningen, Germany, 78054
        • Gemeinschaftspraxis am Bärenplatz
      • Wiesbaden, Germany, 65183
        • Diabetolog. Schwerpunktpraxis
      • Zierenberg, Germany, 34289
        • Internistische Praxis
      • Zossen, Germany, 15806
        • Arztpraxis Zossen / Dabendorf

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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% (≥ 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
Other: 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
from Baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Diabetes Care Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD001732

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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