Covid19NCT04623697
Covid-19 Infection and New Onset Type 1 Diabetes
An observational study of Covid19 and type1diabetes, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, type1diabetes
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 31 Dec 2024
- How long will I take part?
- 2 Years
- 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: All newly diagnosed people with type 1 diabetes
Who may be able to join
- T1D patients diagnosed according to standard practice (including Hba1c, C-peptide, presence of GAD (or islet-cell) antibodies).
- Patient is attending a hospital unit in Denmark or Portugal, due to T1D.
- Age 18 years or above.
Who cannot join
- Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hospital of South West Jutland
Esbjerg, 6700
Claus B Juhl, MD, PhD, +4560867172, claus.bogh.juhl@rsyd.dk
Morten Bjerregaard-Andersen, MSc, PhD, +4528112956, Morten.Bjerregaard-Andersen2@rsyd.dk
About this study
Official title: Covid-19 and Type 1 Diabetes - a Multicenter Study
Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor, which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction.
Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes. This will be done in two ways: a clinical study and an epidemiological follow up. During the next two years, adult patients with newly diagnosed type 1 diabetes will be asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function. People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion. In addition, we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years.
Read the detailed description
Background
Although recognized as an autoimmune disease, the etiology of type 1 diabetes mellitus (T1D) remains undetermined. One dominant hypothesis is that a recent virus infection elicits or enhances an autoimmune reaction, resulting in CD4+ and CD8+ T-cells recognizing pancreatic antigens and subsequently targeting the beta-cells of the pancreas. This results in a gradual but irreversible loss of beta-cell function.
Various enterovirus species have been suspected as causative factors of T1D. However, many different viruses may carry the potential to induce T1D via one of the above-mentioned mechanisms, including respiratory infections.
Most people are presently immunologically inert to SARS-Cov-2, but a large proportion of the world's population is expected to be infected over the next few years, with the global focus having now shifted to slowing the spread (1). The pandemic of COVID-19 therefore provides an opportunity to study a possible correlation between a novel type of virus infection and the development of T1D.
Aim
Our overall aim is to study the impact of Covid-19 on the incidence and the phenotype (beta-cell function at time of diagnosis and at follow up) of newly diagnosed adult patients with T1D in a multicenter study, with enrolments to occur in both Denmark and Portugal.
Method
The following study populations are established over a two-year period, beginning in October 2020:
- Study population 1: Newly diagnosed adult patients with T1D according to usual practice, stratified for the presence of SARS-Cov-2-antibodies (+/-), in both Denmark and Portugal.
- Study population 2: A control population of the same age (+/- 3 years) and sex from each participant country, potentially from the national blood banks. This will provide the SARS-Cov-2 status of the background population. Each newly diagnosed T1D patient is matched with five control persons.
Study 1: Clinical study: Study 1:
Inclusion criteria:
- T1D patients diagnosed according to standard practice (including Hba1c, C-peptide, presence of GAD (or islet-cell) antibodies).
- Patient is attending a hospital unit in Denmark or Portugal, due to T1D.
- Age 18 years or above.
Exclusion criteria:
- Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.
In each country, all subjects from study population 1 will undergo the following assessments at diagnosis of T1D:
- SARS-Cov-2 antibody measurement.
- GAD-antibodies (and if necessary islet cell antibodies (IA-2)).
- HbA1c, fasting blood glucose and fasting C-peptide.
- Mixed-meal tolerance test (MMTT).
- Follow-up one year after the diagnosis with HbA1c, fasting blood glucose, fasting C-peptide and MMTT.
Study 2: Epidemiological study 1: In each country, the incidence of SARS-Covid-2 antibodies in study group 1 is compared to the matched control group (Study population 2).
Study 3: Epidemiological study 2: Independently of the above mentioned study, the incidence of newly diagnosed T1D patients in each participant country will be determined by registry data from January 1st 2020 on a monthly basis and compared with newly diagnosed T1D patients from the two previous years (2018 and 2019).
Outcomes
The study will have the following outcomes
Study 1 (clinical study):
Primary outcome: C-peptide AUC of the MMTT at baseline and one year follow-up, for adult T1D patients having SARS-Cov-2 positive vs. negative antibody status.
Secondary outcomes: Fasting glucose, C-peptide, Hba1c at baseline and one year follow-up, for adult T1D patients having SARS-Cov-2 positive vs. negative antibody status.
Study 2 (epidemiological study 1):
Outcome: Proportion of T1D patients having SARS-Cov-2 antibodies, compared to matched controls from the background population, potentially from the national blood banks (1:5 match on age, gender and if possible country region).
Study 3 (epidemiological study 2):
Outcome: Annual and monthly T1D incidence (cases/100.000) during 2020-2022, compared to 2018 and 2019 in Denmark and Portugal.
- Conditions
- Covid19, type1diabetes
- Keywords
- Covid19, Type 1 diabetes
- Medical subject headings
- COVID-19, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulated insulin secretion
C-peptide AUC of the MMTT at baseline and one year follow-up
Measured: One years
Secondary outcomes (2)
HbA1c
HbA1c measure at one year
Measured: One years
Fasting blood glucose
Fasting blood glucose
Measured: One years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Nordjylland, Aarhus University Hospital, Steno Diabetes Center Sjaelland, Steno Diabetes Center Copenhagen
- Responsible party
- Principal investigator, Claus Bogh Juhl, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Claus B Juhl, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623697
- Sponsor's protocol ID
- S-20200119
- Status last verified
- Oct 2023
- First submitted
- 9 Nov 2020
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filippi CM, von Herrath MG. Viral trigger for type 1 diabetes: pros and cons. Diabetes. 2008 Nov;57(11):2863-71. doi: 10.2337/db07-1023. No abstract available.
PubMed 18971433Coleman TJ, Gamble DR, Taylor KW. Diabetes in mice after Coxsackie B 4 virus infection. Br Med J. 1973 Jul 7;3(5870):25-7. doi: 10.1136/bmj.3.5870.25.
PubMed 4577716Christoffersson G, Flodstrom-Tullberg M. Mouse Models of Virus-Induced Type 1 Diabetes. Methods Mol Biol. 2020;2128:93-105. doi: 10.1007/978-1-0716-0385-7_7.
PubMed 32180188Stone VM, Hankaniemi MM, Svedin E, Sioofy-Khojine A, Oikarinen S, Hyoty H, Laitinen OH, Hytonen VP, Flodstrom-Tullberg M. A Coxsackievirus B vaccine protects against virus-induced diabetes in an experimental mouse model of type 1 diabetes. Diabetologia. 2018 Feb;61(2):476-481. doi: 10.1007/s00125-017-4492-z. Epub 2017 Nov 18.
PubMed 29151123Hyoty H, Leon F, Knip M. Developing a vaccine for type 1 diabetes by targeting coxsackievirus B. Expert Rev Vaccines. 2018 Dec;17(12):1071-1083. doi: 10.1080/14760584.2018.1548281. Epub 2018 Nov 29.
PubMed 30449209Moltchanova EV, Schreier N, Lammi N, Karvonen M. Seasonal variation of diagnosis of Type 1 diabetes mellitus in children worldwide. Diabet Med. 2009 Jul;26(7):673-8. doi: 10.1111/j.1464-5491.2009.02743.x.
PubMed 19573115Karaoglan M, Eksi F. The Coincidence of Newly Diagnosed Type 1 Diabetes Mellitus with IgM Antibody Positivity to Enteroviruses and Respiratory Tract Viruses. J Diabetes Res. 2018 Aug 16;2018:8475341. doi: 10.1155/2018/8475341. eCollection 2018.
PubMed 30186878Patterson CC, Gyurus E, Rosenbauer J, Cinek O, Neu A, Schober E, Parslow RC, Joner G, Svensson J, Castell C, Bingley PJ, Schoenle E, Jarosz-Chobot P, Urbonaite B, Rothe U, Krzisnik C, Ionescu-Tirgoviste C, Weets I, Kocova M, Stipancic G, Samardzic M, de Beaufort CE, Green A, Soltesz G, Dahlquist GG. Seasonal variation in month of diagnosis in children with type 1 diabetes registered in 23 European centers during 1989-2008: little short-term influence of sunshine hours or average temperature. Pediatr Diabetes. 2015 Dec;16(8):573-80. doi: 10.1111/pedi.12227. Epub 2014 Oct 15.
PubMed 25316271Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.
PubMed 18948167Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
PubMed 19333547Bjerregaard-Andersen M, Hostrup PE, Kolnes KJ, Bangshaab M, Andries AR, Silva JD, Carvalho E, Hansen TK, Vestergaard P, Pociot F, Hojlund K, Juhl CB. COVID-19 infection prior to the onset of type 1 diabetes does not impair beta-cell function: a two-year nationwide follow-up study. BMC Endocr Disord. 2026 Jun 15. doi: 10.1186/s12902-026-02358-z. Online ahead of print.
PubMed 42298525
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 and Type 1 Diabetes - a Multicenter Study
- ClinicalTrials.gov ID
- NCT04623697
- Acronym / sponsor ID
- S-20200119
- Conditions
- Covid19, type1diabetes
- Keywords
- Covid19, Type 1 diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Odense, Steno Diabetes Center Nordjylland, Aarhus University Hospital, Steno Diabetes Center Sjaelland, Steno Diabetes Center Copenhagen
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Nov 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.
Although recognized as an autoimmune disease the etiology of type 1 diabetes remains unknown. Virus infections has been suggested as a possible agent triggering the autoimmune reaction finally resulting in beta-cell destruction and fate of insulin secretion. SARS Cov-2 virus enters the infected cells by binding to the ACE-2 receptor, which is abundant in many tissues including the pancreas. Accordingly, SARS Covid-19 infection may trigger the development of type 1 diabetes either by an activation of the immune system or directly via beta-cell infection and destruction.
Our aim is to study the impact of the Covid-19 epidemic on the development of type 1 diabetes. This will be done in two ways: a clinical study and an epidemiological follow up. During the next two years, adult patients with newly diagnosed type 1 diabetes will be asked to participate. Type 1 diabetes will be diagnosed by usual means and a mixed meal tolerance test will be performed at time of diagnosis and after one year to evaluate beta-cell function. People with type 1 diabetes and serologically documented previous SARS Covid-19 will be compared with people with no previous infection regarding beta-cell function and fate of insulin secretion. In addition, we will estimate the number of new diagnosed type 1 diabetes patients compared to previous years.
Detailed description
Background
Although recognized as an autoimmune disease, the etiology of type 1 diabetes mellitus (T1D) remains undetermined. One dominant hypothesis is that a recent virus infection elicits or enhances an autoimmune reaction, resulting in CD4+ and CD8+ T-cells recognizing pancreatic antigens and subsequently targeting the beta-cells of the pancreas. This results in a gradual but irreversible loss of beta-cell function.
Various enterovirus species have been suspected as causative factors of T1D. However, many different viruses may carry the potential to induce T1D via one of the above-mentioned mechanisms, including respiratory infections.
Most people are presently immunologically inert to SARS-Cov-2, but a large proportion of the world's population is expected to be infected over the next few years, with the global focus having now shifted to slowing the spread (1). The pandemic of COVID-19 therefore provides an opportunity to study a possible correlation between a novel type of virus infection and the development of T1D.
Aim
Our overall aim is to study the impact of Covid-19 on the incidence and the phenotype (beta-cell function at time of diagnosis and at follow up) of newly diagnosed adult patients with T1D in a multicenter study, with enrolments to occur in both Denmark and Portugal.
Method
The following study populations are established over a two-year period, beginning in October 2020:
- Study population 1: Newly diagnosed adult patients with T1D according to usual practice, stratified for the presence of SARS-Cov-2-antibodies (+/-), in both Denmark and Portugal.
- Study population 2: A control population of the same age (+/- 3 years) and sex from each participant country, potentially from the national blood banks. This will provide the SARS-Cov-2 status of the background population. Each newly diagnosed T1D patient is matched with five control persons.
Study 1: Clinical study: Study 1:
Inclusion criteria:
- T1D patients diagnosed according to standard practice (including Hba1c, C-peptide, presence of GAD (or islet-cell) antibodies).
- Patient is attending a hospital unit in Denmark or Portugal, due to T1D.
- Age 18 years or above.
Exclusion criteria:
- Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.
In each country, all subjects from study population 1 will undergo the following assessments at diagnosis of T1D:
- SARS-Cov-2 antibody measurement.
- GAD-antibodies (and if necessary islet cell antibodies (IA-2)).
- HbA1c, fasting blood glucose and fasting C-peptide.
- Mixed-meal tolerance test (MMTT).
- Follow-up one year after the diagnosis with HbA1c, fasting blood glucose, fasting C-peptide and MMTT.
Study 2: Epidemiological study 1: In each country, the incidence of SARS-Covid-2 antibodies in study group 1 is compared to the matched control group (Study population 2).
Study 3: Epidemiological study 2: Independently of the above mentioned study, the incidence of newly diagnosed T1D patients in each participant country will be determined by registry data from January 1st 2020 on a monthly basis and compared with newly diagnosed T1D patients from the two previous years (2018 and 2019).
Outcomes
The study will have the following outcomes
Study 1 (clinical study):
Primary outcome: C-peptide AUC of the MMTT at baseline and one year follow-up, for adult T1D patients having SARS-Cov-2 positive vs. negative antibody status.
Secondary outcomes: Fasting glucose, C-peptide, Hba1c at baseline and one year follow-up, for adult T1D patients having SARS-Cov-2 positive vs. negative antibody status.
Study 2 (epidemiological study 1):
Outcome: Proportion of T1D patients having SARS-Cov-2 antibodies, compared to matched controls from the background population, potentially from the national blood banks (1:5 match on age, gender and if possible country region).
Study 3 (epidemiological study 2):
Outcome: Annual and monthly T1D incidence (cases/100.000) during 2020-2022, compared to 2018 and 2019 in Denmark and Portugal.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newly diagnosed people with type 1 diabetes
Key inclusion criteria (3 listed)
- T1D patients diagnosed according to standard practice (including Hba1c, C-peptide, presence of GAD (or islet-cell) antibodies).
- Patient is attending a hospital unit in Denmark or Portugal, due to T1D.
- Age 18 years or above.
Key exclusion criteria (1 listed)
- Severe psychiatric disorder or other conditions deemed to impair the patient's informed consent and participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stimulated insulin secretion
Time frame: One years
C-peptide AUC of the MMTT at baseline and one year follow-up
2 secondary outcomes
HbA1c
Time frame: One years
Fasting blood glucose
Time frame: One years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Results publication: PubMed 18971433Filippi CM, von Herrath MG. Viral trigger for type 1 diabetes: pros and cons. Diabetes. 2008 Nov;57(11):2863-71. doi: 10.2337/db07-1023. No abstract available.
- Results publication: PubMed 4577716Coleman TJ, Gamble DR, Taylor KW. Diabetes in mice after Coxsackie B 4 virus infection. Br Med J. 1973 Jul 7;3(5870):25-7. doi: 10.1136/bmj.3.5870.25.
- Results publication: PubMed 32180188Christoffersson G, Flodstrom-Tullberg M. Mouse Models of Virus-Induced Type 1 Diabetes. Methods Mol Biol. 2020;2128:93-105. doi: 10.1007/978-1-0716-0385-7_7.
- Results publication: PubMed 29151123Stone VM, Hankaniemi MM, Svedin E, Sioofy-Khojine A, Oikarinen S, Hyoty H, Laitinen OH, Hytonen VP, Flodstrom-Tullberg M. A Coxsackievirus B vaccine protects against virus-induced diabetes in an experimental mouse model of type 1 diabetes. Diabetologia. 2018 Feb;61(2):476-481. doi: 10.1007/s00125-017-4492-z. Epub 2017 Nov 18.
- Results publication: PubMed 30449209Hyoty H, Leon F, Knip M. Developing a vaccine for type 1 diabetes by targeting coxsackievirus B. Expert Rev Vaccines. 2018 Dec;17(12):1071-1083. doi: 10.1080/14760584.2018.1548281. Epub 2018 Nov 29.
- Results publication: PubMed 19573115Moltchanova EV, Schreier N, Lammi N, Karvonen M. Seasonal variation of diagnosis of Type 1 diabetes mellitus in children worldwide. Diabet Med. 2009 Jul;26(7):673-8. doi: 10.1111/j.1464-5491.2009.02743.x.
- Results publication: PubMed 30186878Karaoglan M, Eksi F. The Coincidence of Newly Diagnosed Type 1 Diabetes Mellitus with IgM Antibody Positivity to Enteroviruses and Respiratory Tract Viruses. J Diabetes Res. 2018 Aug 16;2018:8475341. doi: 10.1155/2018/8475341. eCollection 2018.
- Results publication: PubMed 25316271Patterson CC, Gyurus E, Rosenbauer J, Cinek O, Neu A, Schober E, Parslow RC, Joner G, Svensson J, Castell C, Bingley PJ, Schoenle E, Jarosz-Chobot P, Urbonaite B, Rothe U, Krzisnik C, Ionescu-Tirgoviste C, Weets I, Kocova M, Stipancic G, Samardzic M, de Beaufort CE, Green A, Soltesz G, Dahlquist GG. Seasonal variation in month of diagnosis in children with type 1 diabetes registered in 23 European centers during 1989-2008: little short-term influence of sunshine hours or average temperature. Pediatr Diabetes. 2015 Dec;16(8):573-80. doi: 10.1111/pedi.12227. Epub 2014 Oct 15.
- Results publication: PubMed 18948167Bindom SM, Lazartigues E. The sweeter side of ACE2: physiological evidence for a role in diabetes. Mol Cell Endocrinol. 2009 Apr 29;302(2):193-202. doi: 10.1016/j.mce.2008.09.020. Epub 2008 Oct 1.
- Results publication: PubMed 19333547Yang JK, Lin SS, Ji XJ, Guo LM. Binding of SARS coronavirus to its receptor damages islets and causes acute diabetes. Acta Diabetol. 2010 Sep;47(3):193-9. doi: 10.1007/s00592-009-0109-4. Epub 2009 Mar 31.
- Derived from this study: PubMed 42298525Bjerregaard-Andersen M, Hostrup PE, Kolnes KJ, Bangshaab M, Andries AR, Silva JD, Carvalho E, Hansen TK, Vestergaard P, Pociot F, Hojlund K, Juhl CB. COVID-19 infection prior to the onset of type 1 diabetes does not impair beta-cell function: a two-year nationwide follow-up study. BMC Endocr Disord. 2026 Jun 15. doi: 10.1186/s12902-026-02358-z. Online ahead of print.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Claus B Juhl principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
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 Covid19 and type1diabetes, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 1 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 Oct 2023. 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 Denmark. 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 Claus B Juhl, MD PhD (+4560867172, Claus.Bogh.Juhl@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulated insulin secretion (time frame: One years). 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 NCT04623697, which also lists 11 linked publications.
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 Oct 2023.