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Type II Diabetes MellitusPDMProValueDSPNCT02156349

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

A study testing Accu-Chek Smart Pix Software and Accu-Chek Smart Pix readout Device in people with Type II Diabetes Mellitus, run by Hoffmann-La Roche at 50 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type II Diabetes Mellitus
What is being tested?
Accu-Chek Smart Pix Software and Accu-Chek Smart Pix readout Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
558 participants
Where
50 sitesGermany
Study dates
14 May 2014to 10 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

Germany50 sites

  • Private Practice

    Altenstadt, 63674

  • Internistische Gemeinschaftspraxis

    Augsburg, 86179

  • Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)

    Bad Mergentheim, 97980

  • Private Practice

    Bad Säckingen, 79713

  • Private Practice

    Berlin, 01627

  • MVZ am Bahnhof Spandau

    Berlin, 13597

  • Gemeinschaftspraxis

    Bitburg, 54634

  • Private Practice

    Buxtehude, 21614

  • Praxis Kugler

    Cologne, 50858

  • Private Practice

    Cuxhaven, 27474

  • Diabetologicum Dresden

    Dresden, 01219

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Gemeinschaftspraxis Schaden

    Düsseldorf, 40212

  • Private Practice

    Essen, 45329

  • Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin

    Falkensee, 14612

  • Private Practice

    Frankfurt am Main, 60326

  • Gemeinschaftspraxis

    Fulda, 36039

  • Private Practice

    Gelnhausen, 63571

  • Hausärztliche internistische Gemeinschaftspraxis Giessen

    Giessen, 35390

  • Diabetes- und Gesundheitszentrum Göttingen

    Göttingen, 37073

  • Private Practice

    Gummersbach, 51645

  • Private Practice

    Hamburg, 21109

  • Diabeteszentrum

    Hamburg, 22119

  • Private Practice

    Hanau, 63450

  • Integriertes Diabetiker-Zentrum Hannover

    Hanover, 30159

  • Gemeinschaftspraxis

    Herne, 44653

  • Gemeinschaftspraxis im Altstadt-Carree

    Hessen, 36037

  • Private Practice

    Immenhausen, 34376

  • Universitätsklinikum Jena, Klinik für Innere Medizin III

    Jena, 07743

  • Diabeteszentrum Kassel

    Kassel, 34117

  • Internistische Praxis Lampertheim

    Lampertheim, 68623

  • Private Practice

    Lauf (Pegnitz), 91207

  • Private Practice

    Laupheim, 88471

  • Private Practice

    Lingen, 49808

  • Diabetes-Zentrum Neustadt

    Neustadt am Rübenberge, 31535

  • Diabetologische Schwerpunktpraxis

    Nordrhein-Westfalen, 46537

  • Private Practice

    Offenbach, 63065

  • Diabetes Praxis Oranienburg

    Oranienburg, 16515

  • Arztpraxis fur Allg-Med

    Pirna, 01796

  • Private Practice

    Porta Westfalica, 32457

  • Private Practice

    Rehburg-Loccum, 31547

  • Gemeinschaftspraxis

    Rhaunen, 55624

  • Pivate Practice

    Rüsselsheim am Main, 65428

  • Ambulanzzentrum Schweinfurt

    Schweinfurt, 97421

  • Versdias Gmbh

    Sulzbach-Rosenberg, 92237

  • Private Practice

    Trier, 54292

  • Gemeinschaftspraxis am Bärenplatz

    Villingen-Schwenningen, 78054

  • Diabetolog. Schwerpunktpraxis

    Wiesbaden, 65183

  • Internistische Praxis

    Zierenberg, 34289

  • Arztpraxis Zossen / Dabendorf

    Zossen, 15806

Other trials in Germany

About this study

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)

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.

Read the 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.

Being tested
Accu-Chek Smart Pix Software, Accu-Chek Smart Pix readout Device
Keywords
Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accu-Chek Smart Pix SoftwareDevice

    Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)

  • Accu-Chek Smart Pix readout DeviceDevice

    Smartpix device for data upload out of blood glucose meter devices

Study groups in NCT02156349
Study groupRoleWhat they receive
Control GroupOtherPatients 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.
Receives: Device: Accu-Chek Smart Pix readout Device
Intervention groupOtherPatients are treated according to the concept "Integrated personalized diabetes management".
Receives: Device: Accu-Chek Smart Pix Software

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods

    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.

    Measured: from Baseline to 12 months

Secondary outcomes (1)

  1. Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2014 (estimated)
  2. Study start14 May 2014
  3. Primary completion10 Apr 2017
  4. Study completion10 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156349
Sponsor's protocol ID
RD001732
Acronym
PDMProValueDSP
Status last verified
Nov 2017
First submitted
3 Jun 2014
Last updated
14 Nov 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Accu-Chek Smart Pix Software and Accu-Chek Smart Pix readout Device in people with Type II Diabetes Mellitus, run by Hoffmann-La Roche at 50 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean HbA1c change by means of Generalized Estimating Equations (GEE) methods (time frame: from Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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