Immune response and therapy assessment to COVID-19 Vaccinations in people with Diabetes Mellitus – an observational pilot study

Immune response and therapy assessment to COVID-19 Vaccinations in people with Diabetes Mellitus – an observational pilot study - COVACDIA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024879

Enrollment

Registered

2021-06-02

Start date

2021-05-19

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 E11

Interventions

Group 1: Diabetes mellitus Type 1, well controlled Glycated haemoglobin levels (HbA1c =7.5 %), observation of physiological reaction to Covid-19 vaccination (vaccination is given independent of study

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: • Planned COVID-19 vaccination(Each participant) • Cohort I (Diabetes mellitus Type 1, well controlled) Glycated haemoglobin levels HbA1c =7.5 % • Cohort II (Diabetes mellitus Type 1, uncontrolled) Glycated haemoglobin levels HbA1c >7.5 % • Cohort III (Diabetes mellitus Type 2, well controlled) Glycated haemoglobin levels HbA1c =7.5 % • Cohort IV (Diabetes mellitus Type 2, uncontrolled) Glycated haemoglobin levels HbA1c >7.5 %

Exclusion criteria

Exclusion criteria: •Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma •Pregnancy or intention of becoming pregnant; breastfeeding •Immunosuppressive therapy •Acute inflammatory disorder •Alcohol abuse (more than 15 drinks / week) •Any contraindication to the vaccine planned to receive as listed in the product characteristics •Previous COVID-19 vaccine or episode of COVID-19 / Healthy control group: •Presence of disease or therapies that are likely to interfere with the immune response to vaccination •Presence of a disease requiring change in therapy during 4 weeks prior to enrollment •Any contraindications to the vaccine planned to receive as listed in the product characteristics •Women who are pregnant, breastfeeding or not following adequate contraceptive measures •Previous vaccination with any coronavirus vaccine or episode of COVID-19

Design outcomes

Primary

Measure	Time frame
• Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.	—

Secondary

Measure	Time frame
• Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 2 (1-2 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls. • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between people with diabetes (all 4 groups pooled) and healthy controls. • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between the 4 groups of people with diabetes • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between the 4 groups of people with diabetes • Differences in the immune phenotype (B cell and T cell subsets) between the 5 cohorts before the vaccination • Immune phenotype predictors (B cell subsets, T cell subsets) at baseline for the anti-SARS-CoV-2 spike protein humoral immune response at Visit 3 based on immune-phenotyping patterns at baseline (B cell subsets, T cell subsets) • Glycaemic profiles (time in range, time below range and time above range), number of hypoglycaemia (15 min via isCGM/CGM) and hyperglycaemia (>180 mg/dL and >250 mg/dL), glycaemic variability (%CV, SD), post-prandial glucose excursion, and therapy (total daily insulin dose [basal rate/basal insulin and bolus insulin], carbohydrate to insulin ratio, number and amount of insulin corrections) the week following the vaccination as compared to period before the vaccination (for both vaccinations time points; except for single dose injections) • Difference in the change of coagulation parameters from baseline to Visit 2 in people with diabetes and healthy controls. • Difference in the change of coagulation parameters from baseline to Visit 3 in people with d	—

Measure

Time frame

• Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 2 (1-2 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls. • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between people with diabetes (all 4 groups pooled) and healthy controls. • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between the 4 groups of people with diabetes • Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between the 4 groups of people with diabetes • Differences in the immune phenotype (B cell and T cell subsets) between the 5 cohorts before the vaccination • Immune phenotype predictors (B cell subsets, T cell subsets) at baseline for the anti-SARS-CoV-2 spike protein humoral immune response at Visit 3 based on immune-phenotyping patterns at baseline (B cell subsets, T cell subsets) • Glycaemic profiles (time in range, time below range and time above range), number of hypoglycaemia (15 min via isCGM/CGM) and hyperglycaemia (>180 mg/dL and >250 mg/dL), glycaemic variability (%CV, SD), post-prandial glucose excursion, and therapy (total daily insulin dose [basal rate/basal insulin and bolus insulin], carbohydrate to insulin ratio, number and amount of insulin corrections) the week following the vaccination as compared to period before the vaccination (for both vaccinations time points; except for single dose injections) • Difference in the change of coagulation parameters from baseline to Visit 2 in people with diabetes and healthy controls. • Difference in the change of coagulation parameters from baseline to Visit 3 in people with d

—

Countries

Germany

Contacts

Public ContactOthmar Moser

Division Exercise Physiology and Metabolism

othmar.moser@uni-bayreuth.de+49 (0)921 / 55-3465

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026