Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients 70 Years Old and Over : a Cohort Study.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Association Pour la Recherche en Diabetologie et en Geriatrie
ClinicalTrials.gov Identifier:
NCT01282060
First received: January 21, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 21, 2011
January 21, 2011
March 2009
July 2015   (final data collection date for primary outcome measure)
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No Changes Posted
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Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients 70 Years Old and Over : a Cohort Study.
Association Between Glycaemic Control and Morbi/Mortality After 5 Years of Follow-up in Type 2 Diabetic Patients .

The purpose of this study is to asses the link between glycaemic balance (summarised by HBA1C LEVEL) and specific causes of death.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
  • Patients suffering from type 2 diabetes and aged 70 and over.
  • Having received medicinal or non-medicinal therapy (in the case of diabetics treated with insulin, the lengh of time between diagnosis of diabtees and the introduction of insulin therapy is at least 6 months).
  • Suffering from type 2 diabetes at least one year.
  • With autonomy defined by a score greater than or equal to 3/6 on the ADL scale and able of being followed-up during hospital or private consultations over the next 5 years.
  • Patients who did not refuse to participate in the study after receiving information on the study (Patient Information Leaflet).

The patient are monitored in the hospital or private sector throughout Metropolitan France.

Diabetes Mellitus, Type 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
986
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July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with type 2 diabetes, aged 70 and over,
  • Patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years),
  • Diabetes diagnosed for at least one year,
  • Patient with autonomy defined by a score greater than or equal to 3/6 on the ADL scale,
  • Patient who can be monitored during hospital or private consultations over the next 10 years,
  • Patient who did not refuse to take part in the study after receiving information on the study (Patient Information Leaflet), Patients are monitored in the hospital or private sector throughout France.

Exclusion Criteria:

  • Patient with type 1 diabetes,
  • Patient with secondary diabetes (mainly corticosteroid-induced),
  • Patient with a loss of autonomy defined by a score of less than 3/6 on the ADL scale,
  • Patient who cannot be monitored in the months or years to come,
  • Patient in an acute situation (transient exclusion criterion),
  • Patient expressing their refusal to participate in the study.
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01282060
CRO0662-1
Yes
Pr DOUCET jean, GERODIAB
Association Pour la Recherche en Diabetologie et en Geriatrie
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Association Pour la Recherche en Diabetologie et en Geriatrie
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP