A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
NCT ID: NCT02156349
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
558 participants
INTERVENTIONAL
2014-05-14
2017-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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".
Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Accu-Chek Smart Pix Software
Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
Accu-Chek Smart Pix readout Device
Smartpix device for data upload out of blood glucose meter devices
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roche Diabetes Care
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iris Vesper
Role: STUDY_DIRECTOR
Roche Diabetes Care
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Private Practice
Altenstadt, , Germany
Internistische Gemeinschaftspraxis
Augsburg, , Germany
Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM)
Bad Mergentheim, , Germany
Private Practice
Bad Säckingen, , Germany
Private Practice
Berlin, , Germany
MVZ am Bahnhof Spandau
Berlin, , Germany
Gemeinschaftspraxis
Bitburg, , Germany
Private Practice
Buxtehude, , Germany
Praxis Kugler
Cologne, , Germany
Private Practice
Cuxhaven, , Germany
Diabetologicum Dresden
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Gemeinschaftspraxis Schaden
Düsseldorf, , Germany
Private Practice
Essen, , Germany
Schwerpunktpraxis für Diabetes, Gefäß- und Ernährungsmedizin
Falkensee, , Germany
Private Practice
Frankfurt am Main, , Germany
Gemeinschaftspraxis
Fulda, , Germany
Private Practice
Gelnhausen, , Germany
Hausärztliche internistische Gemeinschaftspraxis Giessen
Giessen, , Germany
Diabetes- und Gesundheitszentrum Göttingen
Göttingen, , Germany
Private Practice
Gummersbach, , Germany
Private Practice
Hamburg, , Germany
Diabeteszentrum
Hamburg, , Germany
Private Practice
Hanau, , Germany
Integriertes Diabetiker-Zentrum Hannover
Hanover, , Germany
Gemeinschaftspraxis
Herne, , Germany
Gemeinschaftspraxis im Altstadt-Carree
Hessen, , Germany
Private Practice
Immenhausen, , Germany
Universitätsklinikum Jena, Klinik für Innere Medizin III
Jena, , Germany
Diabeteszentrum Kassel
Kassel, , Germany
Internistische Praxis Lampertheim
Lampertheim, , Germany
Private Practice
Lauf (Pegnitz), , Germany
Private Practice
Laupheim, , Germany
Private Practice
Lingen, , Germany
Diabetes-Zentrum Neustadt
Neustadt am Rübenberge, , Germany
Diabetologische Schwerpunktpraxis
Nordrhein-Westfalen, , Germany
Private Practice
Offenbach, , Germany
Diabetes Praxis Oranienburg
Oranienburg, , Germany
Arztpraxis fur Allg-Med
Pirna, , Germany
Private Practice
Porta Westfalica, , Germany
Private Practice
Rehburg-Loccum, , Germany
Gemeinschaftspraxis
Rhaunen, , Germany
Pivate Practice
Rüsselsheim am Main, , Germany
Ambulanzzentrum Schweinfurt
Schweinfurt, , Germany
Versdias Gmbh
Sulzbach-Rosenberg, , Germany
Private Practice
Trier, , Germany
Gemeinschaftspraxis am Bärenplatz
Villingen-Schwenningen, , Germany
Diabetolog. Schwerpunktpraxis
Wiesbaden, , Germany
Internistische Praxis
Zierenberg, , Germany
Arztpraxis Zossen / Dabendorf
Zossen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD001732
Identifier Type: -
Identifier Source: org_study_id