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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Incidence analysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case : ADRS group<br>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<br>* 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.<br>* Other names: Standardized Incidence Ratios (SIR);|
| Control : non ADRS Group<br>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<br>* 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.<br>* Other names: Standardized Incidence Ratios (SIR);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control | 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) | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Diabetes complications | ≥ 1 annual eye examination, defined by a visit to an ophthalmologist or a dilated fundus examination, in or out of the hospitals | one year | 
| Hypoglycemia | ≥ 1 annual hospitalization for hypoglycemia | one year | 
| ketoacidosis without coma | ≥ 1 annual hospitalization for ketoacidosis without coma | one year | 
| diabetic coma | - ≥ 1 annual hospitalization for diabetic coma (with ketoacidosis, hyperosmolar or hypoglycemia) | one year | 
| diabetic nephropathy | ≥ 1 annual hospitalization for diabetic nephropathy | one year | 
| diabetic neuropathy | ≥ 1 annual hospitalization for diabetic neuropathy | one year | 
| hospitalization for any of the 5 previous diabetes-related cause | ≥ 1 annual hospitalization for any of the 5 previous diabetes-related cause | one year | 
| hospitalization for falls and femoral fracture | ≥ 1 annual hospitalization for falls and femoral fracture | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Alzheimer Disease or related disorders