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NCT Number: NCT03565809

Quality of the Management of Diabetes in Elderly People With Dementia in France

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Toulouse, 31000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Incidence analysis

Other

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 names: Standardized Incidence Ratios (SIR)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study 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

Acronym: DIA-FRADEM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2018
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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