Clinical trial NCT03565809: Quality of the Management of Diabetes in Elderly People With Dementia in France
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Diabetes mellitus
Alzheimer Disease or related disorders
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-06-21
Enrollment: 87816
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Diabetes control
timeFrame: one year
Secondary outcomes:
measure: Ocular Diabetes complications
timeFrame: one year
measure: Hypoglycemia
timeFrame: one year
measure: ketoacidosis without coma
timeFrame: one year
measure: diabetic coma
timeFrame: one year
measure: diabetic nephropathy
timeFrame: one year
measure: diabetic neuropathy
timeFrame: one year
measure: hospitalization for any of the 5 previous diabetes-related cause
timeFrame: one year
measure: hospitalization for falls and femoral fracture
timeFrame: one year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Virginie Gardette, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wargny M, Gallini A, Hanaire H, Nourhashemi F, Andrieu S, Gardette V. Diabetes Care and Dementia Among Older Adults: A Nationwide 3-Year Longitudinal Study. J Am Med Dir Assoc. 2018 Jul;19(7):601-606.e2. doi: 10.1016/j.jamda.2017.12.006. Epub 2018 Feb 1.