Clinical trial NCT00916513: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey
Official title: Quality of Life and Treatment Satisfaction of People With Type 2 Diabetes: A European Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Treatment Satisfaction
Quality of Life
HbA1c levels and goals
Healthcare resources consumption
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 5926
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries

Brief summary: The present European survey seeks to assess quality of life and satisfaction with treatment in people with T2DM and to appreciate disease and treatment variables including hypoglycaemia and level of glycaemic control. It will also provide relevant information on other important aspects such as the level of correlation of objective measures such as HbA1c with health status, QoL and satisfaction with current treatment. Overall 5000 randomly selected patients will be invited to participate from a representative sample of clinical practices during a pre-specified period. The study will entail a single patient visit. Patients who agree to the study and give their informed consent will complete questionnaires which, combined with retrospective notes review \& an HbA1c test, will allow patient, disease and treatment variables to be collected. An HbA1c test is a finger prick test to measure glycosylated haemoglobin in the blood indicating the level of blood glucose over the last 8-12 weeks.


Eligibility criteria: Inclusion Criteria:

* With T2DM, diagnosed at least 1 year prior to entry in the study
* Currently treated with diet, OAD(s) and/or insulin with no change in the type of OAD(s) or insulin in the previous three months

Exclusion Criteria:

* Type 1 diabetes and/or history of diabetic ketoacidosis
* Secondary diabetes (including disease of the exocrine pancreas, endocrinopathies or drug-induced)
* Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed

Primary outcomes:
measure: Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D
timeFrame: Cross-sectional and retrospective
Secondary outcomes:
measure: Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications
timeFrame: Retrospective (previous 24 months)
measure: Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)
timeFrame: Retrospective (previous 24 months)
Other outcomes:
Locations:
city: Antibes
country: France
facility: Research Site
city: Athies
country: France
facility: Research Site
city: Audruicq
country: France
facility: Research Site
city: Auxerre
country: France
facility: Research Site
city: Baigneux les Juifs
country: France
facility: Research Site
city: Baume les Dames
country: France
facility: Research Site
city: Beaumont sur leze
country: France
facility: Research Site
city: Beaurepaire
country: France
facility: Research Site
city: Beauvais
country: France
facility: Research Site
city: Berat
country: France
facility: Research Site
city: Bettacourt la Ferree
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Bezons
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Boulogne sur Gesse
country: France
facility: Research Site
city: Bresles
country: France
facility: Research Site
city: Brest Cedex 3
country: France
facility: Research Site
city: Breteuil Sur Iton
country: France
facility: Research Site
city: Bruere Allichamps
country: France
facility: Research Site
city: Bulles
country: France
facility: Research Site
city: Burry
country: France
facility: Research Site
city: Cany Barville
country: France
facility: Research Site
city: Capdenac Gare
country: France
facility: Research Site
city: Cappelle Brouck
country: France
facility: Research Site
city: Carquefou
country: France
facility: Research Site
city: Carresse Cassaber
country: France
facility: Research Site
city: Carros
country: France
facility: Research Site
city: Celles sur Plaine
country: France
facility: Research Site
city: Chabons
country: France
facility: Research Site
city: Champagnole
country: France
facility: Research Site
city: Champigny Sur Marne
country: France
facility: Research Site
city: Chanmpdeniers St Denis
country: France
facility: Research Site
city: Chartrettes
country: France
facility: Research Site
city: Chatillon sur Colmont
country: France
facility: Research Site
city: Chauvigny
country: France
facility: Research Site
city: Clairac
country: France
facility: Research Site
city: Clichy
country: France
facility: Research Site
city: Comps
country: France
facility: Research Site
city: Concarneu
country: France
facility: Research Site
city: Courbevoie
country: France
facility: Research Site
city: Courpiere
country: France
facility: Research Site
city: Coutances
country: France
facility: Research Site
city: Coutouvre
country: France
facility: Research Site
city: Dambach La Ville
country: France
facility: Research Site
city: Dieulouard
country: France
facility: Research Site
city: Digoin
country: France
facility: Research Site
city: Donges
country: France
facility: Research Site
city: Douchy Les Mines
country: France
facility: Research Site
city: Drap
country: France
facility: Research Site
city: Equeurdreville Hainneville
country: France
facility: Research Site
city: Escaudain
country: France
facility: Research Site
city: Faverges
country: France
facility: Research Site
city: Fenouillet
country: France
facility: Research Site
city: Firmi
country: France
facility: Research Site
city: Francoville la Garenne
country: France
facility: Research Site
city: Fruges
country: France
facility: Research Site
city: Gelles
country: France
facility: Research Site
city: Gondrecourt le Chateau
country: France
facility: Research Site
city: Guitalens L' Albarede
country: France
facility: Research Site
city: Hanvec
country: France
facility: Research Site
city: Houilles
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: Ivry Sur Seine
country: France
facility: Research Site
city: Jussey
country: France
facility: Research Site
city: L' Hay Les Roses
country: France
facility: Research Site
city: La Courneuve
country: France
facility: Research Site
city: La Crau
country: France
facility: Research Site
city: La Ferte st Aubin
country: France
facility: Research Site
city: La Mulatiere
country: France
facility: Research Site
city: La Tranche sur Mer
country: France
facility: Research Site
city: Lamagistere
country: France
facility: Research Site
city: Lanouaille
country: France
facility: Research Site
city: Laroquebrou
country: France
facility: Research Site
city: Lathus st Remy
country: France
facility: Research Site
city: Le Cannet
country: France
facility: Research Site
city: Le Grand Lemps
country: France
facility: Research Site
city: Le Havre
country: France
facility: Research Site
city: Le Monastier sur Gazeille
country: France
facility: Research Site
city: Le Nouvion en Thierache
country: France
facility: Research Site
city: Le Pertre
country: France
facility: Research Site
city: Le Plessis Trevise
country: France
facility: Research Site
city: Le Pontet
country: France
facility: Research Site
city: Les Mees
country: France
facility: Research Site
city: Leyme
country: France
facility: Research Site
city: Lezignan Corbieres
country: France
facility: Research Site
city: Locmiquelic
country: France
facility: Research Site
city: Luneray
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Magland
country: France
facility: Research Site
city: Maintenon
country: France
facility: Research Site
city: Mantes La Ville
country: France
facility: Research Site
city: Marcq en Baroeul
country: France
facility: Research Site
city: Marles les Mines
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mauleon Soule
country: France
facility: Research Site
city: Mayet
country: France
facility: Research Site
city: Meximieux
country: France
facility: Research Site
city: Mezzavia
country: France
facility: Research Site
city: Miramas
country: France
facility: Research Site
city: Monce en Berlin
country: France
facility: Research Site
city: Montelimar
country: France
facility: Research Site
city: Montfort en Chalosse
country: France
facility: Research Site
city: Montoire Sur le Loir
country: France
facility: Research Site
city: Montreuil
country: France
facility: Research Site
city: Monts sur Guesnes
country: France
facility: Research Site
city: Mussidan
country: France
facility: Research Site
city: Narbonne
country: France
facility: Research Site
city: Neuilly Les Dijon
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Niederschaeffolsheim
country: France
facility: Research Site
city: Noisy Le Sec
country: France
facility: Research Site
city: Nordausques
country: France
facility: Research Site
city: Nouatre
country: France
facility: Research Site
city: Oberhausbergen
country: France
facility: Research Site
city: Orchies
country: France
facility: Research Site
city: Orlienas
country: France
facility: Research Site
city: Ormes
country: France
facility: Research Site
city: Pantin
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pauillac
country: France
facility: Research Site
city: Pau
country: France
facility: Research Site
city: Pernes les Fontaines
country: France
facility: Research Site
city: Pibrac
country: France
facility: Research Site
city: Pierrepont sur Avre
country: France
facility: Research Site
city: Pitgam
country: France
facility: Research Site
city: Plancoet
country: France
facility: Research Site
city: Pleneuf val Andre
country: France
facility: Research Site
city: Plouvorn
country: France
facility: Research Site
city: Pornic
country: France
facility: Research Site
city: Port La Nouvelle
country: France
facility: Research Site
city: Pradines
country: France
facility: Research Site
city: Puilley Les Vignes
country: France
facility: Research Site
city: Puttelange aux Lacs
country: France
facility: Research Site
city: Quessoy
country: France
facility: Research Site
city: Quiberon
country: France
facility: Research Site
city: Quimper
country: France
facility: Research Site
city: Rambervillers
country: France
facility: Research Site
city: Renaze
country: France
facility: Research Site
city: Richemont
country: France
facility: Research Site
city: Robion
country: France
facility: Research Site
city: Romainville
country: France
facility: Research Site
city: Rombas
country: France
facility: Research Site
city: Romorantin Lanthenay
country: France
facility: Research Site
city: Salles
country: France
facility: Research Site
city: Salome
country: France
facility: Research Site
city: Sassenage
country: France
facility: Research Site
city: Sault les Rethel
country: France
facility: Research Site
city: Soissons
country: France
facility: Research Site
city: Soisy sur Ecole
country: France
facility: Research Site
city: Soyaux
country: France
facility: Research Site
city: St Andre de Sangonis
country: France
facility: Research Site
city: St Aubin des Chateaux
country: France
facility: Research Site
city: St Bonnet le Chateau
country: France
facility: Research Site
city: St Jean de Maurienne
country: France
facility: Research Site
city: St Laurent d Aigouze
country: France
facility: Research Site
city: St Martin des Champs
country: France
facility: Research Site
city: St Saens
country: France
facility: Research Site
city: St Thuriau
country: France
facility: Research Site
city: St Yorre
country: France
facility: Research Site
city: Ste Menehould
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Thann
country: France
facility: Research Site
city: Thure
country: France
facility: Research Site
city: Toufflers
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Tourcoing
country: France
facility: Research Site
city: Troyes
country: France
facility: Research Site
city: Uzes
country: France
facility: Research Site
city: Vailly Sur Aisne
country: France
facility: Research Site
city: Valenton
country: France
facility: Research Site
city: Valras Plage
country: France
facility: Research Site
city: Vaugneray
country: France
facility: Research Site
city: Villefagnan
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Villeurbanne
country: France
facility: Research Site
city: Vitry Le Francois
country: France
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Alsdorf
country: Germany
facility: Research Site
city: Ampfing
country: Germany
facility: Research Site
city: Aschersleben
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Freienwalde
country: Germany
facility: Research Site
city: Bad Staffelstein
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Biberbach
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Edenkoben
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Eschweiler
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frechen
country: Germany
facility: Research Site
city: Fuchsstadt
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: G�ntersleben
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heinsberg
country: Germany
facility: Research Site
city: Holzkirchen
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Iserlohn
country: Germany
facility: Research Site
city: Kaisersesch
country: Germany
facility: Research Site
city: Kalkar
country: Germany
facility: Research Site
city: Kehl
country: Germany
facility: Research Site
city: Kirchheim
country: Germany
facility: Research Site
city: Klingenberg
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marpingen
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Oberursel
country: Germany
facility: Research Site
city: Pretzfeld
country: Germany
facility: Research Site
city: Reit im Winkl
country: Germany
facility: Research Site
city: Rimbach
country: Germany
facility: Research Site
city: Sand
country: Germany
facility: Research Site
city: Schwaig
country: Germany
facility: Research Site
city: Sinntal
country: Germany
facility: Research Site
city: Sonthofen
country: Germany
facility: Research Site
city: Westerkappeln
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Zweibrucken
country: Germany
facility: Research Site
city: Zwenkau
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Belfast
country: Ireland
facility: Research Site
city: Co. ANRTIM
country: Ireland
facility: Research Site
city: Andria
country: Italy
facility: Research Site
state: Bari
city: Latina
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Viterbo
country: Italy
facility: Research Site
city: Beilen
country: Netherlands
facility: Research Site
state: Drenthe
city: Coevorden
country: Netherlands
facility: Research Site
state: Drenthe
city: Zwartemeer
country: Netherlands
facility: Research Site
state: Drenthe
city: Almere
country: Netherlands
facility: Research Site
state: Flevoland
city: Drachten
country: Netherlands
facility: Research Site
state: Friesland
city: Lichtenvoorde
country: Netherlands
facility: Research Site
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Research Site
state: Gelderland
city: Onstwedde
country: Netherlands
facility: Research Site
state: Groningen
city: Maastricht
country: Netherlands
facility: Research Site
state: Limburg
city: Vlodorp
country: Netherlands
facility: Research Site
state: Limburg
city: Beek en Donk
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Den Bosch
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Etten-Leur
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Lieshout
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Schijndel
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Soerendonk
country: Netherlands
facility: Research Site
state: Noord-Braband
city: Edam
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Hoogwoud
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Huizen
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Volendam
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Ermelo
country: Netherlands
facility: Research Site
state: Overijssel
city: Heeten
country: Netherlands
facility: Research Site
state: Overijssel
city: Hengelo
country: Netherlands
facility: Research Site
state: Overijssel
city: Nijverdal
country: Netherlands
facility: Research Site
state: Overijssel
city: Tubbergen
country: Netherlands
facility: Research Site
state: Overijssel
city: Amersfoort
country: Netherlands
facility: Research Site
state: Utrecht
city: Poortvliet
country: Netherlands
facility: Research Site
state: Zeeland
city: Bennebroek
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Den Haag
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Dordrecht
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Lisse
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Rijswijk
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Roelofarendsveen
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Spijkernisse
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Woerden
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Cadiz
country: Spain
facility: Research Site
state: Andalucia
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Burgos
country: Spain
facility: Research Site
state: Castilla Y Leon
city: Manresa
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Catalu�a
city: Elche
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Pontevedra
country: Spain
facility: Research Site
state: Galicia
city: Gran Canaria
country: Spain
facility: Research Site
state: Las Palmas De Gran Canaria
city: Coslada
country: Spain
facility: Research Site
state: Madrid
city: Fuenlabrada
country: Spain
facility: Research Site
state: Madrid
city: Madrid
country: Spain
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Bedford
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackburn
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Bury St Edmunds
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Canterbury
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Cornwall
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Darlington
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Penzance
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Salisbury
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: St Albans
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Medical Department.AstraZeneca Spain
name: Angeles Porta
role: STUDY_DIRECTOR
References:
citation: Bradley C, Eschwege E, de Pablos-Velasco P, Parhofer KG, Simon D, Vandenberghe H, Gonder-Frederick L. Predictors of Quality of Life and Other Patient-Reported Outcomes in the PANORAMA Multinational Study of People With Type 2 Diabetes. Diabetes Care. 2018 Feb;41(2):267-276. doi: 10.2337/dc16-2655. Epub 2017 Nov 28.
citation: Simon D, de Pablos-Velasco P, Parhofer KG, Gonder-Frederick L, Duprat Lomon I, Vandenberghe H, Eschwege E, Bradley C. Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study. Diabetes Metab. 2015 Dec;41(6):470-9. doi: 10.1016/j.diabet.2015.08.007. Epub 2015 Oct 9.
citation: de Pablos-Velasco P, Parhofer KG, Bradley C, Eschwege E, Gonder-Frederick L, Maheux P, Wood I, Simon D. Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study. Clin Endocrinol (Oxf). 2014 Jan;80(1):47-56. doi: 10.1111/cen.12119. Epub 2013 May 6.
citation: Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwege E, Gonder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus--study design. Prim Care Diabetes. 2011 Dec;5(4):231-9. doi: 10.1016/j.pcd.2011.04.004. Epub 2011 Jul 14.