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

Diabetes Mellitus, Type 2 Clinical Trial

— PDM-ProValueGP  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268929
• Other study ID #: RD001231
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: November 22, 2017
• Start date: October 14, 2014
• Est. completion date: February 9, 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: 414
• Est. completion date: February 9, 2017
• Est. primary completion date: January 11, 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% 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)

• 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

Exclusion Criteria:

• 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)

• 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

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 from blood glucose meter devices

Locations

Country	Name	City	State
n/a

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 Generalized Estimating Equations (GEE) methods		from Baseline to 12 months
Secondary	Effects of integrated Personalized Diabetes Management (PDM) by means of Generalized Estimating Equations [GEE] methods		12 months