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Diabetes Mellitus, Type 2PDM-ProValueGPNCT02268929

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

A study testing Accu-Chek Smart Pix Software and Accu-Chek Smart Pix readout Device in people with Diabetes Mellitus, Type 2, 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
Diabetes Mellitus, Type 2
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
414 participants
Where
50 sitesGermany
Study dates
14 Oct 2014to 9 Feb 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% 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)
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  • 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

Who cannot join

  • 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)
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  • 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

  • Study site

    Albstadt, 72461

  • Study site

    Auerbach/Vogtland, 08209

  • Study site

    Bad Kreuznach, 55545

  • Study site

    Beucha, 04824

  • Study site

    Beutel/Templin, 17268

  • Study site

    Blankenhain, 99444

  • Study site

    Bochum, 44805

  • Study site

    Bockenem, 31167

  • Study site

    Borna, 04552

  • Study site

    Bremerhaven, 27572

  • Study site

    Cloppenburg, 49661

  • Study site

    Dransfeld, 37127

  • Study site

    Dresden, 01309

  • Study site

    Düren, 52349

  • Study site

    Elsterwerda, 04910

  • Study site

    Essen, 45329

  • Study site

    Essen, 45355

  • Study site

    Essen, 45359

  • Study site

    Föhren, 54343

  • Study site

    Geringswalde, 09326

  • Study site

    Giessen, 35390

  • Study site

    Hanover, 30163

  • Study site

    Hemsbach, 69502

  • Study site

    Herborn, 35745

  • Study site

    Kerpen, 50169

  • Study site

    Köthen, 06366

  • Study site

    Krefeld, 47803

  • Study site

    Kreuzau, 52372

  • Study site

    Leipzig, 04315

  • Study site

    Löhne, 32584

  • Study site

    Lübeck, 23562

  • Study site

    Mainz, 55116

  • Study site

    Mainz, 55130

  • Study site

    Meissen, 01662

  • Study site

    Meudt, 56414

  • Study site

    Papenburg, 26871

  • Study site

    Reinfeld, 23858

  • Study site

    Riesa, 01589

  • Study site

    Rochlitz, 09328

  • Study site

    Rodgau, 63110

  • Study site

    Schleiden, 53937

  • Study site

    Schwedt, 16303

  • Study site

    Schweich, 54338

  • Study site

    Schweich, 54343

  • Study site

    Siegen, 57072

  • Study site

    Sigmaringen, 72488

  • Study site

    Staufenberg, 35460

  • Study site

    Trier, 54290

  • Study site

    Weida, 07570

  • Study site

    Wetzlar, 35584

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 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.

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
Medical subject headings
Diabetes Mellitus, Type 2

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 from blood glucose meter devices

Study groups in NCT02268929
Study groupRoleWhat they receive
Control GroupOtherPatients treated by usual customary medical practice (Usual Care)
Receives: Device: Accu-Chek Smart Pix readout Device
Intervention GroupOtherPatients treated with "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 Generalized Estimating Equations (GEE) methods

    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 posted20 Oct 2014 (estimated)
  2. Study start14 Oct 2014
  3. Primary completion11 Jan 2017
  4. Study completion9 Feb 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
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02268929
Sponsor's protocol ID
RD001231
Acronym
PDM-ProValueGP
Status last verified
Nov 2017
First submitted
16 Oct 2014
Last updated
24 Nov 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
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 Diabetes Mellitus, Type 2, 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 9 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 24 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 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 NCT02268929.

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 24 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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