Quality of the Management of Diabetes in Elderly People With Dementia in France (DIA-FRADEM)

August 31, 2021 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87816

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Standardized Incidence Ratios (SIR)
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
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.
Other Names:
  • Standardized Incidence Ratios (SIR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes control
Time Frame: 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)
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Virginie Gardette, MD PhD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8256

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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