Alzheimer DiseaseDIA-FRADEMNCT03565809
Quality of the Management of Diabetes in Elderly People With Dementia in France
An observational study of Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Incidence analysis
- How many people
- 87,816 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Incidence analysis
- Keywords
- Diabetes mellitus, Alzheimer Disease or related disorders
- Medical subject headings
- Alzheimer Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence analysisOther
Also called Standardized Incidence Ratios (SIR)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Incidence analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year
Secondary outcomes (8)
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
Measured: one year
Hypoglycemia
≥ 1 annual hospitalization for hypoglycemia
Measured: one year
ketoacidosis without coma
≥ 1 annual hospitalization for ketoacidosis without coma
Measured: one year
diabetic coma
- ≥ 1 annual hospitalization for diabetic coma (with ketoacidosis, hyperosmolar or hypoglycemia)
Measured: one year
diabetic nephropathy
≥ 1 annual hospitalization for diabetic nephropathy
Measured: one year
diabetic neuropathy
≥ 1 annual hospitalization for diabetic neuropathy
Measured: one year
hospitalization for any of the 5 previous diabetes-related cause
≥ 1 annual hospitalization for any of the 5 previous diabetes-related cause
Measured: one year
hospitalization for falls and femoral fracture
≥ 1 annual hospitalization for falls and femoral fracture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start2 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 87,816 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Gardette, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565809
- Sponsor's protocol ID
- RC31/16/8256
- Acronym
- DIA-FRADEM
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29396187
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03565809
- Acronym / sponsor ID
- DIA-FRADEM / RC31/16/8256
- Conditions
- Alzheimer Disease
- Keywords
- Diabetes mellitus, Alzheimer Disease or related disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87,816 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 2 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case : ADRS group | – | Other: Incidence analysisIncidence 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. |
| Control : non ADRS Group | – | Other: Incidence analysisIncidence 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incidence analysisAlso: Standardized Incidence Ratios (SIR)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 | Case : ADRS group, Control : non ADRS Group |
Primary outcome
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)
8 secondary outcomes
Ocular Diabetes complications
Time frame: one year
Hypoglycemia
Time frame: one year
ketoacidosis without coma
Time frame: one year
diabetic coma
Time frame: one year
diabetic nephropathy
Time frame: one year
diabetic neuropathy
Time frame: one year
hospitalization for any of the 5 previous diabetes-related cause
Time frame: one year
hospitalization for falls and femoral fracture
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Results publication: PubMed 29396187Wargny 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Gardette, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes control (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.