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

Type II Diabetes Mellitus Clinical Trial

— PDMProValueDSP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156349
• Other study ID #: RD001732
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

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