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

Alzheimer Disease Clinical Trial

— DIA-FRADEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565809
• Other study ID #: RC31/16/8256
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87816
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Incidence 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.

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hypoglycemia	= 1 annual hospitalization for hypoglycemia	one year
Secondary	ketoacidosis without coma	= 1 annual hospitalization for ketoacidosis without coma	one year
Secondary	diabetic coma	- = 1 annual hospitalization for diabetic coma (with ketoacidosis, hyperosmolar or hypoglycemia)	one year
Secondary	diabetic nephropathy	= 1 annual hospitalization for diabetic nephropathy	one year
Secondary	diabetic neuropathy	= 1 annual hospitalization for diabetic neuropathy	one year
Secondary	hospitalization for any of the 5 previous diabetes-related cause	= 1 annual hospitalization for any of the 5 previous diabetes-related cause	one year
Secondary	hospitalization for falls and femoral fracture	= 1 annual hospitalization for falls and femoral fracture	one year