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

NCT03565809 | Completed

• 1 other identifier: RC31/16/8256
• Study Type: observational
• Target: 87,816
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Diabetes mellitus; Alzheimer Disease or related disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ocular Diabetes complications

  one year

• Hypoglycemia

  one year

• ketoacidosis without coma

  one year

• diabetic coma

  one year

• diabetic nephropathy

  one year

Study Arms (2)

Case : ADRS group

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

Control : non ADRS Group

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

Interventions

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.

Also known as: Standardized Incidence Ratios (SIR)

Case : ADRS group; Control : non ADRS Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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").

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

University Hospital

Toulouse, 31000, France

Location

Related Publications (1)

• 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.

  PMID: 29396187 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Diabetes Mellitus

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Virginie Gardette, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: May 2, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

FR (1)