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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03565809
Acronym
DIA-FRADEM
Enrollment
87816
Registered
2018-06-21
Start date
2017-05-02
Completion date
2018-12-31
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Diabetes mellitus, Alzheimer Disease or related disorders

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.

Interventions

OTHERIncidence 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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Toulouse
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetes controlone yearGiven 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

MeasureTime frameDescription
Hypoglycemiaone year≥ 1 annual hospitalization for hypoglycemia
ketoacidosis without comaone year≥ 1 annual hospitalization for ketoacidosis without coma
diabetic comaone year\- ≥ 1 annual hospitalization for diabetic coma (with ketoacidosis, hyperosmolar or hypoglycemia)
Ocular Diabetes complicationsone year≥ 1 annual eye examination, defined by a visit to an ophthalmologist or a dilated fundus examination, in or out of the hospitals
diabetic neuropathyone year≥ 1 annual hospitalization for diabetic neuropathy
hospitalization for any of the 5 previous diabetes-related causeone year≥ 1 annual hospitalization for any of the 5 previous diabetes-related cause
hospitalization for falls and femoral fractureone year≥ 1 annual hospitalization for falls and femoral fracture
diabetic nephropathyone year≥ 1 annual hospitalization for diabetic nephropathy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026