Association of Coronavirus Disease 2019 and Development of Type 1 Diabetes: A Danish Nationwide Register Study.

OBJECTIVE: To compare the incidence of type 1 diabetes (T1D) before and during the coronavirus disease 2019 (COVID-19) pandemic and determine whether severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is associated with T1D development. RESEARCH DESIGN AND METHODS: All Danish residents age <30 years free of diabetes from 2015 to 2021 were included. Individuals were followed from 1 January 2015 or birth until the development of T1D, the age of 30, the end of the study (31 December 2021), emigration, development of type 2 diabetes, onset of any cancer, initiation of immunomodulating therapy, or development of any autoimmune disease. We compared the incidence rate ratio (IRR) of T1D using Poisson regression models. We matched each person with a SARS-CoV-2 infection with three control persons and used a cause-specific Cox regression model to estimate the hazard ratio (HR). RESULTS: Among 2,381,348 individuals, 3,579 cases of T1D occurred. The adjusted IRRs for T1D in each quarter of 2020 and 2021 compared with 2015-2019 were as follows: January-March 2020, 1.03 (95% CI 0.86; 1.23); January-March 2021, 1.01 (0.84; 1.22), April-June 2020, 0.98 (0.80; 1.20); April-June 2021, 1.34 (1.12; 1.61); July-September 2020, 1.13 (0.94; 1.35); July-September 2021, 1.21 (1.01; 1.45); October-December 2020, 1.09 (0.91; 1.31); and October-December 2021, 1.18 (0.99; 1.41). We identified 338,670 individuals with a positive SARS-CoV-2 test result and matched them with 1,004,688 control individuals. A SARS-2-CoV infection was not significantly associated with the risk of T1D development (HR 0.90 [95% CI 0.60; 1.35]). CONCLUSIONS: There was an increase in T1D incidence during April-June 2021 compared with April-June 2015-2019, but this could not be attributed to SARS-CoV-2 infection.

Behavioral factors associated with SARS-CoV-2 infection.

OBJECTIVE: To study the association between behavioural factors and incidence rates of SARS-CoV-2 infection. DESIGN: Case-control web-based questionnaire study. SETTING: Questionnaire data were collected in the Capital Region of Denmark in December 2020 when limited restrictions were in place, while the number of daily SARS-CoV-2 cases increased rapidly. PARTICIPANTS: 8913 cases of laboratory-confirmed SARS-CoV-2 infection were compared with two groups of controls: (1) 34 063 individuals with a negative SARS-CoV-2 test from the same date (negative controls, NCs) and 2) 25 989 individuals who had never been tested for a SARS-CoV-2 infection (untested controls, UC). Controls were matched on sex, age, test date and municipality. EXPOSURE: Activities during the 14 days prior to being tested positive for SARS-CoV-2 or during the same period for matched controls and precautions taken during the entire pandemic. MAIN OUTCOMES AND MEASURES: SARS-CoV-2 infection incidence rate ratios (IRR). RESULTS: Response rate was 41.4% (n=93 121). Using public transportation, grocery shopping (IRR: NC: 0.52; UC: 0.63) and outdoor sports activities (NC: 0.75; UC: 0.96) were not associated with increased rate of SARS-CoV-2 infection. Most precautions, for example, using hand sanitizer (NC: 0.79; UC: 0.98), physical distancing (NC: 0.79; UC: 0.82) and avoiding handshakes (NC: 0.74; UC: 0.77), were associated with a lower rate of infection. Activities associated with many close contacts, especially indoors, increased rate of infection. Except for working from home, all types of occupation were linked to increased rate of infection. CONCLUSIONS: In a community setting with moderate restrictions, activities such as using public transportation and grocery shopping with the relevant precautions were not associated with an increased rate of SARS-CoV-2 infection. Exposures and activities where safety measures are difficult to maintain might be important risk factors for infection. These findings may help public health authorities tailor their strategies for limiting the spread of SARS-CoV-2.

Behavioral factors associated with SARS-CoV-2 infection

Objective To study the association between behavioural factors and incidence rates of SARS-CoV-2 infection. Design Case–control web-based questionnaire study. Setting Questionnaire data were collected in the Capital Region of Denmark in December 2020 when limited restrictions were in place, while the number of daily SARS-CoV-2 cases increased rapidly. Participants 8913 cases of laboratory-confirmed SARS-CoV-2 infection were compared with two groups of controls: (1) 34 063 individuals with a negative SARS-CoV-2 test from the same date (negative controls, NCs) and 2) 25 989 individuals who had never been tested for a SARS-CoV-2 infection (untested controls, UC). Controls were matched on sex, age, test date and municipality. Exposure Activities during the 14 days prior to being tested positive for SARS-CoV-2 or during the same period for matched controls and precautions taken during the entire pandemic. Main outcomes and measures SARS-CoV-2 infection incidence rate ratios (IRR). Results Response rate was 41.4% (n=93 121). Using public transportation, grocery shopping (IRR: NC: 0.52;UC: 0.63) and outdoor sports activities (NC: 0.75;UC: 0.96) were not associated with increased rate of SARS-CoV-2 infection. Most precautions, for example, using hand sanitizer (NC: 0.79;UC: 0.98), physical distancing (NC: 0.79;UC: 0.82) and avoiding handshakes (NC: 0.74;UC: 0.77), were associated with a lower rate of infection. Activities associated with many close contacts, especially indoors, increased rate of infection. Except for working from home, all types of occupation were linked to increased rate of infection. Conclusions In a community setting with moderate restrictions, activities such as using public transportation and grocery shopping with the relevant precautions were not associated with an increased rate of SARS-CoV-2 infection. Exposures and activities where safety measures are difficult to maintain might be important risk factors for infection. These findings may help public health authorities tailor their strategies for limiting the spread of SARS-CoV-2.

Insulin Pump Treatment in Adults with Type 1 Diabetes in the Capital Region of Denmark: Design and Cohort Characteristics of the Steno Tech Survey.

INTRODUCTION: Insulin pump therapy can improve quality of life and glycaemic outcomes for many people with type 1 diabetes (T1D). The multidimensional Steno Tech Survey study aims to investigate why some insulin pump users do not achieve treatment goals. In this article, we present the study design and analyse differences in population characteristics between responders and non-responders. METHODS: In June 2020, all 1591 insulin pump users (≥ 18 years) in the Capital Region of Denmark were invited to participate in an online questionnaire that evaluated several dimensions of insulin pump self-management and psychosocial health. Demographic, socioeconomic and clinical characteristics, including age, sex and HbA1c, of the cohort were identified via national registries. Predictors of questionnaire response/non-response were explored with logistic regression analysis. RESULTS: In the full study population, 58% were female, median age was 42 years and median HbA1c was 58 mmol/mol (7.5%); 30% had HbA1c < 53 mmol/mol (7.0%). In total, 770 individuals (48%) responded to the questionnaire. Logistic regression analysis showed that 50+ years of age (odds ratio [OR] = 2.3, 95% confidence interval [CI]: 1.4-3.8), female sex (OR = 1.3, CI: 1.02-1.6), being married (OR = 1.8, CI: 1.3-2.4) and having long higher education (OR = 1.6, CI: 1.004-2.5) were significantly associated with a higher likelihood of responding to the survey; the opposite was found for HbA1c from 64 to < 75 mmol (8.0-9.0%) (OR = 0.6, CI: 0.4-0.8) and HbA1c ≥ 75 mmol/mol (≥ 9.0%) (OR = 0.2, CI: 0.1-0.3). CONCLUSIONS: The established Steno Tech cohort enables future analysis of a range of psychosocial and behavioural aspects of insulin pump self-management. Interpretation and generalization of findings should consider observed differences between responders and non-responders.

Telemetric Continuous Glucose Monitoring During the COVID-19 Pandemic in Isolated Hospitalized Patients in Denmark: A Randomized Controlled Exploratory Trial.

Objective: To investigate whether telemetric continuous glucose monitoring (CGM) in hospitalized and isolated patients with diabetes mellitus and coronavirus disease 2019 (COVID-19) is associated with better glycemic outcomes and fewer patient health care worker contacts compared to blood glucose monitoring by traditional point-of-care (POC) glucose testing and to investigate the user aspect of implementing a CGM-system in-hospital. Materials and Methods: A randomized controlled exploratory trial was performed on hospitalized and isolated patients with diabetes and COVID-19 from May 2020 until February 2021 at Nordsjællands Hospital, Denmark. Participants were randomized to nonblinded telemetric CGM (as the only glucose monitoring method) or traditional POC glucose testing + blinded CGM. The primary endpoint was time in range (TIR) based on CGM data in both groups. A questionnaire about the user aspect of the CGM system was answered by health care personnel (HCP). Results: We included 64 participants in the analysis, 31 in the CGM group and 33 in the POC glucose group. TIR median was 46% for the CGM group and 68% for the POC glucose group (P = 0.368). The mean glucose value for the CGM group was 11.1 and 10.8 mmol/L in the POC glucose group (P = 0.372). CGM was associated with fewer POC glucose measurements (P < 0.001). Out of 30 HCPs, 28 preferred telemetric CGM over POC glucose testing. Conclusion: Remote glucose monitoring by CGM did not improve glycemic outcomes compared to traditional POC glucose testing, but was associated with fewer patient-personnel contacts, saving time for HCPs performing diabetes-related tasks. Most HCPs preferred CGM. The study is registered at http://www.clinicaltrials.gov (#NCT04430608).

Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: Patients with diabetes are - compared to people without diabetes - at increased risk of worse outcomes from COVID-19 related pneumonia during hospitalization. We aim to investigate whether telemetric continuous glucose monitoring (CGM) in quarantined hospitalized patients with diabetes and confirmed SARS-CoV-2 infection or another contagious infection can be successfully implemented and is associated with better glycaemic control than usual blood glucose monitoring (finger prick method) and fewer patient-health care worker contacts. Furthermore, we will assess whether glucose variables are associated with the clinical outcome. The hypothesis is that by using remote CGM to monitor glucose levels of COVID-19 infected patients and patients with other contagious infections with diabetes, we can still provide satisfactory (and maybe even better) in-hospital diabetes management despite patients being quarantined. Furthermore, the number of patient-personnel contacts can be lowered compared to standard monitoring with finger-prick glucose. This could potentially reduce the risk of transmitting contagious diseases from the patient to other people and reduces the use of PPE's. Improved glucose control may reduce the increased risk of poor clinical outcomes associated with combined diabetes and infection. TRIAL DESIGN: This is a single centre, open label, exploratory, randomised, controlled, 2-arm parallel group (1:1 ratio), controlled trial. PARTICIPANTS: The trial population is patients with diabetes (both type 1 diabetes, type 2 diabetes, newly discovered diabetes that is not classified yet, and all other forms of diabetes) admitted to Nordsjællands Hospital that are quarantined due to COVID-19 infection or another infection. INCLUSION CRITERIA: 1. Hospitalized with confirmed COVID-19 infection by real-time PCR or another validated method OR hospitalized with a non-COVID-19 diagnosis and quarantined at time of inclusion. 2. A documented clinically relevant history of diabetes or newly discovered during hospitalization as defined by The World Health Organizations diagnostic criteria for diabetes. 3. Written informed consent obtained before any trial related procedures are performed. 4. Male or female aged over 18 years of age. 5. Must be able to communicate with the study personnel. 6. The subject must be willing and able to comply with trial protocol. EXCLUSION CRITERIA: 1. Known hypersensitivity to the band-aid of the Dexcom G6 sensors INTERVENTION AND COMPARATOR: Participants will be randomized to either real-time CGM with the Dexcom G6, a CGM system that does not need to be calibrated, or finger-prick glucose monitoring. Blinded CGM will be mounted in the finger-prick group. In the open CGM group, the glucose values will be transmitted to a Smartdevice in the nurse office where glucose levels can be monitored remotely. MAIN OUTCOMES: The primary endpoint is the difference between groups in distribution of glucose values being in time in range (TIR), defined as 3.9 to 10 mmol/l. In addition, the primary endpoint is reported as the percentage of days of the whole admission, the patient reaches TIR. Secondary endpoints are the estimated number of saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization. Furthermore, we will assess additional glucose outcomes and associations of glucose variables and patient outcomes (As specified in the protocol). RANDOMISATION: The service used for generating the randomization lists is www.random.org . Randomization is stratified by COVID-19 status and an allocation ratio of 1:1 to either CGM or finger-prick groups. BLINDING (MASKING): The design of the trial is open, however blinded CGM is recorded in the finger-prick group. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A sample size of N=72 is required for the primary endpoint analysis based on 80% power to detect a 10% difference between groups in TIR and to allow for a 15% dropout. The 72 participants will be randomized 1:1 to open CGM or finger-prick with 36 in each group. TRIAL STATUS: This structured protocol summary is based on the CGM-ISO protocol version 1.3, dated 13.05.2020. Date of first patient enrolled: 25.05.2020. Expected last recruiting is May 2021. Patients enrolled to date: 20 in total. 8 with confirmed COVID-19 infection and 12 with other infections. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04430608 . Registered 12.06.2020 FULL PROTOCOL: The full protocol is attached as an additional file from the Trial website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; This Letter serves as a summary of the key elements of the full protocol.

Characteristics and early outcomes of patients hospitalised for COVID-19 in North Zealand, Denmark

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is an ongoing pandemic associated with significant morbidity and mortality worldwide. Limited data are available describing the clinical presentation and outcomes of hospitalised COVID-19 patients in Europe. METHODS: This was a single-centre retrospective chart review of all patients with COVID-19 admitted to the North Zealand Hospital in Denmark between 1 March and 4 May 2020. Main outcomes include major therapeutic interventions during hospitalisation, such as invasive mechanical ventilation, as well as death. RESULTS: A total of 115 patients were included, including four infants. The median age of adults was 68 years and 40% were female. At admission, 55 (50%) patients had a fever, 29 (26%) had a respiratory rate exceeding 24 breaths/minute, and 78 (70%) received supplemental oxygen. The prevalence of co-infection was 13%. Twenty patients (18%) (median age: 64 years;15% female) were treated in the intensive care unit. Twelve (10.4%) received invasive mechanical ventilation and three (2.6%) renal replacement therapy. Nine patients (8%) developed pulmonary embolism. Sixteen patients (14%) died. Among patients requiring mechanical ventilation (n = 12), seven (6.1%) were discharged alive, four (3.4%) died and one (0.9%) was still hospitalised. CONCLUSION: In this cohort of hospitalised COVID-19 patients, mortality was lower than in other Danish and European case series. FUNDING: none. TRIAL REGISTRATION: not relevant.