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

Completed

• Conditions: Alzheimer Disease
• Interventions: Other: Incidence analysis

• Registration Number: NCT03565809
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87816

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case : ADRS group	Incidence analysis	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.
Control : non ADRS Group	Incidence analysis	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.

Primary Outcome Measures

Name	Time	Method
Diabetes control	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

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France