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Quality of the Management of Diabetes in Elderly People With Dementia in France (DIA-FRADEM)

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ClinicalTrials.gov Identifier: NCT03565809
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Along with population ageing, the association of chronic conditions such as Alzheimer's Disease and Related Syndromes (ADRS) and diabetes mellitus is increasing in clinical practice. According to ADRS severity, guidelines of diabetes care may be adapted for a personalized monitoring and treatment. The consequences on diabetes complications are not known and can also threaten dementia progression. Based on a nationwide healthcare reimbursement database, the present study aimed to compare diabetes care and the incidence of acute complications between patients with or without ADRS, in a longitudinal perspective focusing on the pivotal period of ADRS identification by the healthcare system.

Condition or disease Intervention/treatment
Alzheimer Disease Other: Incidence analysis

Study Type : Observational
Estimated Enrollment : 87816 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Quality of the Management of Diabetes in Elderly People With Dementia in France. Longitudinal Study in the French National Health System Database During 2010-2015
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018


Group/Cohort Intervention/treatment
Case : ADRS group
Incidence analysis in ADRS group defined by the first recording of one of the following criteria: (i) LTD registration for ADRS (ICD-10 codes: "F00-F03", "G30", or "G31"), (ii) hospital stay reporting a diagnosis code of ADRS (similar ICD-10 codes) or (iii) reimbursement for at least one acetylcholinesterase inhibitor (rivastigmine, galantamine or donepezil) or memantine.
Other: Incidence analysis
Incidence analysis between the 2 groups (ADRS/non ADRS). For each pair, an index date was defined as the ADRS identification date. In both groups, a 5-year period free of these three ADRS criteria was required before the index date, to ensure incident ADRS cases.
Other Name: Standardized Incidence Ratios (SIR)

Control : non ADRS Group
Incidence analysis in non ADRS group. Each incident ADRS case was paired (1:1) to a beneficiary without any ADRS criteria, matched on age (same birth year), sex, residence area (based on of the 100 administrative 'départements') and insurance scheme.
Other: Incidence analysis
Incidence analysis between the 2 groups (ADRS/non ADRS). For each pair, an index date was defined as the ADRS identification date. In both groups, a 5-year period free of these three ADRS criteria was required before the index date, to ensure incident ADRS cases.
Other Name: Standardized Incidence Ratios (SIR)




Primary Outcome Measures :
  1. Diabetes control [ Time Frame: one year ]

    Given the absence of consensual guidelines describing the frequency of diabetes monitoring among elderly subjects, we defined a conservative minimal threshold as follows: ambulatory biological monitoring :

    • ≥ 1 annual HbA1c determination (primary endpoint)
    • ≥ 2 annual HbA1c determination
    • ≥ 1 annual lipid profile (≥ 1 annual LDL cholesterol, ≥ 1 annual triglyceride)


Secondary Outcome Measures :
  1. Ocular Diabetes complications [ Time Frame: one year ]
    ≥ 1 annual eye examination, defined by a visit to an ophthalmologist or a dilated fundus examination, in or out of the hospitals

  2. Hypoglycemia [ Time Frame: one year ]
    ≥ 1 annual hospitalization for hypoglycemia

  3. ketoacidosis without coma [ Time Frame: one year ]
    ≥ 1 annual hospitalization for ketoacidosis without coma

  4. diabetic coma [ Time Frame: one year ]
    - ≥ 1 annual hospitalization for diabetic coma (with ketoacidosis, hyperosmolar or hypoglycemia)

  5. diabetic nephropathy [ Time Frame: one year ]
    ≥ 1 annual hospitalization for diabetic nephropathy

  6. diabetic neuropathy [ Time Frame: one year ]
    ≥ 1 annual hospitalization for diabetic neuropathy

  7. hospitalization for any of the 5 previous diabetes-related cause [ Time Frame: one year ]
    ≥ 1 annual hospitalization for any of the 5 previous diabetes-related cause

  8. hospitalization for falls and femoral fracture [ Time Frame: one year ]
    ≥ 1 annual hospitalization for falls and femoral fracture



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients included in the FRADEM study : FRADEM is a nationwide case control study conducted through the French national health system database administrative data, the SNDS (systeme national des données de santé). SNDS provies reimbursement data from the entire French general population, whether subjects live at home or in a nursing home, whichever their healthcare schemes, leading to a 97% coverage of the French population in 2011.
Criteria

Inclusion Criteria:

  • individuals with a first ADRS criterion in 2011 or 2012,
  • prevalent diabetes mellitus, defined by a LTD with ICD-10 codes of diabetes mellitus ("E10-E14").
  • at least one reimbursement in the year preceding inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565809


Locations
France
University Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Virginie Gardette, MD PhD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03565809     History of Changes
Other Study ID Numbers: RC31/16/8256
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Diabetes mellitus
Alzheimer Disease or related disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders