NCT00916513

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,926

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Shorter than P25 for all trials

Geographic Reach
8 countries

302 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

10 months

First QC Date

June 5, 2009

Last Update Submit

April 26, 2010

Conditions

Keywords

DiabetesTreatment SatisfactionQuality of LifeHbA1c levels and goalsHealthcare resources consumption

Outcome Measures

Primary Outcomes (1)

  • Diabetes-related QoL and treatment satisfaction questionnaires: DTSQ, ADDQoL, HFSws and EQ5D

    Cross-sectional and retrospective

Secondary Outcomes (2)

  • Disease-related variables: Years with diabetes, use of SMBG and frequency of monitoring, Hypoglycaemic episodes, Past Medical History, Macro and micro-vascular complications

    Retrospective (previous 24 months)

  • Health-economic variables: Use of healthcare resources Days off work (for either hypoglycaemias, acute or chronic complications)

    Retrospective (previous 24 months)

Study Arms (1)

1

Patients ³ 40 years old, with T2DM diagnosed and followed up in the participating site at least 1 year prior to entry in the study, treated with diet, OADs and/or insulin for at least the past three months

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

To be recruited in Primary Care Centres mainly, but hospitals will be allowed in some countries

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (302)

Research Site

Antibes, France

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Athies, France

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Audruicq, France

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Auxerre, France

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Baigneux-les-Juifs, France

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Baume-les-Dames, France

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Beaumont-sur-Lèze, France

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Beaurepaire, France

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Beauvais, France

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Bettacourt La Ferree, France

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Bezons, France

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Bérat, France

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Béziers, France

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Blois, France

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Boulogne-sur-Gesse, France

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Bresles, France

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Brest, France

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Breteuil, France

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Bruère-Allichamps, France

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Bulles, France

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Burry, France

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Cany-Barville, France

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Capdenac-Gare, France

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Cappelle-Brouck, France

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Carquefou, France

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Carresse-Cassaber, France

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Carros, France

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Celles-sur-Plaine, France

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Champagnole, France

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Champigny-sur-Marne, France

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Chanmpdeniers Saint Denis, France

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Chartrettes, France

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Chauvigny, France

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Châbons, France

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Châtillon-sur-Colmont, France

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Clairac, France

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Clichy, France

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Comps, France

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Concarneu, France

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Courbevoie, France

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Courpière, France

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Coutances, France

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Coutouvre, France

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Dambach-la-Ville, France

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Dieulouard, France

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Digoin, France

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Donges, France

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Douchy-les-Mines, France

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Drap, France

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Escaudain, France

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Équeurdreville-Hainneville, France

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Faverges, France

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Fenouillet, France

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Firmi, France

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Francoville La Garenne, France

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Fruges, France

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Gelles, France

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Gondrecourt-le-Château, France

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Guitalens-L'Albarède, France

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Hanvec, France

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Houilles, France

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Hyères, France

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Ivry-sur-Seine, France

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Jussey, France

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L'Haÿ-les-Roses, France

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La Courneuve, France

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La Crau, France

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La Ferté-Saint-Aubin, France

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La Mulatière, France

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La Tranche-sur-Mer, France

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Lamagistère, France

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Lanouaille, France

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Laroquebrou, France

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Lathus-Saint-Rémy, France

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Le Cannet, France

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Le Grand-Lemps, France

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Le Havre, France

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Le Monastier-sur-Gazeille, France

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Le Nouvion-en-Thiérache, France

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Le Pertre, France

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Le Plessis-Trévise, France

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Le Pontet, France

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Les Mées, France

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Leyme, France

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Lézignan-Corbières, France

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Locmiquélic, France

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Luneray, France

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Lyon, France

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Magland, France

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Maintenon, France

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Mantes-la-Ville, France

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Marcq-en-Barœul, France

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Marles-les-Mines, France

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Marseille, France

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Mauléon-Licharre, France

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Mayet, France

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Meximieux, France

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Mezzavia, France

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Miramas, France

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Monce En Berlin, France

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Montélimar, France

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Montfort-en-Chalosse, France

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Montoire-sur-le-Loir, France

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Montreuil, France

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Monts-sur-Guesnes, France

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Mussidan, France

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Narbonne, France

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Neuilly-lès-Dijon, France

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Nice, France

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Niederschaeffolsheim, France

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Noisy-le-Sec, France

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Nordausques, France

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Nouâtre, France

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Oberhausbergen, France

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Orchies, France

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Orliénas, France

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Ormes, France

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Pantin, France

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Paris, France

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Pau, France

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Pauillac, France

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Pernes-les-Fontaines, France

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Pibrac, France

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Pierrepont-sur-Avre, France

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Pitgam, France

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Plancoët, France

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Pléneuf-Val-André, France

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Plouvorn, France

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Pornic, France

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Port-La Nouvelle, France

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Pradines, France

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Puilley Les Vignes, France

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Puttelange-aux-Lacs, France

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Quessoy, France

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Quiberon, France

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Quimper, France

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Rambervillers, France

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Renazé, France

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Richemont, France

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Robion, France

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Romainville, France

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Rombas, France

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Romorantin-Lanthenay, France

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Saint-André-de-Sangonis, France

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Saint-Aubin-des-Châteaux, France

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Saint-Bonnet-le-Château, France

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Saint-Jean-de-Maurienne, France

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Saint-Laurent-d'Aigouze, France

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Saint-Martin-des-Champs, France

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Saint-Saëns, France

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Saint-Thuriau, France

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Saint-Yorre, France

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Salles, France

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Salomé, France

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Sassenage, France

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Sault-lès-Rethel, France

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Soissons, France

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Soisy-sur-École, France

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Soyaux, France

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Ste Menehould, France

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Strasbourg, France

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Thann, France

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Thuré, France

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Toufflers, France

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Toulon, France

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Tourcoing, France

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Troyes, France

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Uzès, France

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Vailly-sur-Aisne, France

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Valenton, France

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Valras-Plage, France

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Vaugneray, France

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Villefagnan, France

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Villejuif, France

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Villeurbanne, France

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Vitry-le-François, France

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Aachen, Germany

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Alsdorf, Germany

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Ampfing, Germany

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Aschersleben, Germany

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Augsburg, Germany

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Bad Freienwalde, Germany

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Bad Staffelstein, Germany

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Berlin, Germany

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Biberbach, Germany

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Bonn, Germany

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Coburg, Germany

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Duisburg, Germany

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Edenkoben, Germany

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Erfurt, Germany

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Eschweiler, Germany

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Essen, Germany

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Frechen, Germany

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Fuchsstadt, Germany

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Fulda, Germany

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G�ntersleben, Germany

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Hamburg, Germany

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Heinsberg, Germany

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Holzkirchen, Germany

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Homburg, Germany

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Iserlohn, Germany

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Kaisersesch, Germany

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Kalkar, Germany

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Kehl, Germany

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Kirchheim, Germany

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Klingenberg, Germany

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Ludwigshafen, Germany

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Magdeburg, Germany

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Marpingen, Germany

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Moers, Germany

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München, Germany

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Nuremberg, Germany

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Oberursel, Germany

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Pretzfeld, Germany

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Reit im Winkl, Germany

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Rimbach, Germany

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Sand, Germany

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Schwaig, Germany

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Sinntal, Germany

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Sonthofen, Germany

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Westerkappeln, Germany

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Wiesbaden, Germany

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Zweibrücken, Germany

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Zwenkau, Germany

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Athens, Greece

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Belfast, Ireland

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Co. Anrtim, Ireland

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Andria, Bari, Italy

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Latina, Italy

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Rome, Italy

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Viterbo, Italy

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Beilen, Drenthe, Netherlands

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Coevorden, Drenthe, Netherlands

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Zwartemeer, Drenthe, Netherlands

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Almere Stad, Flevoland, Netherlands

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Lichtenvoorde, Gelderland, Netherlands

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Nijmegen, Gelderland, Netherlands

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Maastricht, Limburg, Netherlands

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Vlodorp, Limburg, Netherlands

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's-Hertogenbosch, Noord-Braband, Netherlands

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Beek en Donk, Noord-Braband, Netherlands

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Etten-Leur, Noord-Braband, Netherlands

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Lieshout, Noord-Braband, Netherlands

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Schijndel, Noord-Braband, Netherlands

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Soerendonk, Noord-Braband, Netherlands

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Edam, North Holland, Netherlands

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Hoogwoud, North Holland, Netherlands

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Huizen, North Holland, Netherlands

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Volendam, North Holland, Netherlands

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Ermelo, Overijssel, Netherlands

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Heeten, Overijssel, Netherlands

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Hengelo, Overijssel, Netherlands

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Nijverdal, Overijssel, Netherlands

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Tubbergen, Overijssel, Netherlands

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Drachten, Provincie Friesland, Netherlands

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Onstwedde, Provincie Groningen, Netherlands

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Bennebroek, South Holland, Netherlands

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Dordrecht, South Holland, Netherlands

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Lisse, South Holland, Netherlands

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Rijswijk, South Holland, Netherlands

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Roelofarendsveen, South Holland, Netherlands

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Rotterdam, South Holland, Netherlands

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Spijkernisse, South Holland, Netherlands

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The Hague, South Holland, Netherlands

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Woerden, South Holland, Netherlands

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Amersfoort, Utrecht, Netherlands

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Poortvliet, Zeeland, Netherlands

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Cadiz, Andalusia, Spain

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Santander, Cantabria, Spain

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Burgos, Castille and León, Spain

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Manresa, Catalonia, Spain

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Barcelona, Catalu�a, Spain

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Pontevedra, Galicia, Spain

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Gran Canaria, Las Palmas de Gran Canaria, Spain

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Coslada, Madrid, Spain

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Fuenlabrada, Madrid, Spain

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Madrid, Madrid, Spain

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Elche, Valencia, Spain

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Bath, United Kingdom

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Bedford, United Kingdom

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Birmingham, United Kingdom

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Blackburn, United Kingdom

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Blackpool, United Kingdom

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Bristol, United Kingdom

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Bury St Edmunds, United Kingdom

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Cambridge, United Kingdom

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Canterbury, United Kingdom

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Cardiff, United Kingdom

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Cornwall, United Kingdom

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Coventry, United Kingdom

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Darlington, United Kingdom

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Glasgow, United Kingdom

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Guildford, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Newcastle, United Kingdom

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Penzance, United Kingdom

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Plymouth, United Kingdom

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Reading, United Kingdom

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Salisbury, United Kingdom

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Sheffield, United Kingdom

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St Albans, United Kingdom

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Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Angeles Porta

    Medical Department.AstraZeneca Spain

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2009

First Posted

June 9, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations