Diabetes MellitusCONFI-DIABNCT04485351
Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes
An observational study of Diabetes Mellitus and Coronavirus Infection, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronavirus Infection, Metabolic Disease
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2020to Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes
Who may be able to join
- Adult patients
- Patient with diabetes known for at least 6 months before inclusion
- Patient followed by a specialist physician from the University Hospital of Nancy for routine care within the 6 months prior to the lockdown.
- Patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition
Who cannot join
- Subjects opposed to the use of their data
- Minors, adults under guardianship, protected persons
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Regional Hospital of Nancy
Nancy
Lisa Ludwig, Dr
About this study
Official title: Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.
The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.
This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
- Being tested
- no intervention
- Keywords
- diabetes mellitus, lockdown, covid-19
- Medical subject headings
- Diabetes Mellitus, Coronavirus Infections, Metabolic Diseases, Glucose Metabolism Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients from the University Hospital of Nancy | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.
HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
Measured: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Secondary outcomes (7)
Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy
Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
Measured: 6 weeks period following the end of the lockdown
Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.
Use BMI, lipid profile, renal and hepatic function from medical records
Measured: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.
Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
Measured: 6 weeks period following the end of the lockdown
Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.
Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
Measured: 6 weeks period following the end of the lockdown
Describe the proportion of patients who changed their lifestyle's habits during the lockdown.
Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco
Measured: 6 weeks period following the end of the lockdown
Describe healthcare consumption of patients with diabetes during the lockdown.
Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)
Measured: 6 weeks period following the end of the lockdown
Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Measured: 6 weeks period following the end of the lockdown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Ludwig, Dr, Principal investigator, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485351
- Sponsor's protocol ID
- 2020PI137
- Acronym
- CONFI-DIAB
- Status last verified
- Jun 2020
- First submitted
- 2 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.
PubMed 34241812
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04485351
- Acronym / sponsor ID
- CONFI-DIAB / 2020PI137
- Keywords
- diabetes mellitus, lockdown, covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 24 Jul 2020 (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.
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.
The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.
This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients from the University Hospital of Nancy | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes
Key inclusion criteria (4 listed)
- Adult patients
- Patient with diabetes known for at least 6 months before inclusion
- Patient followed by a specialist physician from the University Hospital of Nancy for routine care within the 6 months prior to the lockdown.
- Patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition
Key exclusion criteria (2 listed)
- Subjects opposed to the use of their data
- Minors, adults under guardianship, protected persons
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 |
|---|---|---|
| no interventionno intervention | Other | Diabetic patients from the University Hospital of Nancy |
Primary outcome
Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.
Time frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
7 secondary outcomes
Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy
Time frame: 6 weeks period following the end of the lockdown
Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.
Time frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.
Time frame: 6 weeks period following the end of the lockdown
Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.
Time frame: 6 weeks period following the end of the lockdown
Describe the proportion of patients who changed their lifestyle's habits during the lockdown.
Time frame: 6 weeks period following the end of the lockdown
Describe healthcare consumption of patients with diabetes during the lockdown.
Time frame: 6 weeks period following the end of the lockdown
Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Time frame: 6 weeks period following the end of the lockdown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Derived from this study: PubMed 34241812Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.
- Individual participant dataSharing planned: No
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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.
Lisa Ludwig, Dr principal investigator
PA
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 Diabetes Mellitus and Coronavirus Infection, run by Central Hospital, Nancy, France 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Ludwig, Dr (+33383155056, L.LUDWIG@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic. (time frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown). 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 NCT04485351, 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 24 Jul 2020.