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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02156349
Other study ID # RD001732
Secondary ID
Status Completed
Phase N/A
First received June 3, 2014
Last updated November 13, 2017
Start date May 14, 2014
Est. completion date April 10, 2017

Study information

Verified date November 2017
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.


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.


Recruitment information / eligibility

Status Completed
Enrollment 558
Est. completion date April 10, 2017
Est. primary completion date April 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
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

Locations

Country Name City State
Germany Private Practice Altenstadt
Germany Internistische Gemeinschaftspraxis Augsburg
Germany Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM) Bad Mergentheim
Germany Private Practice Bad Sackingen
Germany MVZ am Bahnhof Spandau Berlin
Germany Private Practice Berlin
Germany Gemeinschaftspraxis Bitburg
Germany Private Practice Buxtehude
Germany Private Practice Cuxhaven
Germany Diabetologicum Dresden Dresden
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Gemeinschaftspraxis Schaden Dusseldorf
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 Gottingen
Germany Private Practice Gummersbach
Germany Diabeteszentrum Hamburg
Germany Private Practice Hamburg
Germany Private Practice Hanau
Germany Integriertes Diabetiker-Zentrum Hannover Hannover
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 Praxis Kugler Koln
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 Russelsheim
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

Sponsors (2)

Lead Sponsor Collaborator
Hoffmann-La Roche Roche Diabetes Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. from Baseline to 12 months
Secondary Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods 12 months
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