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Analyzing non-infection-related health care utilization and health outcomes in people with type 2 diabetes during the COVID-19 pandemic: making use of individually linked statutory health insurance data and survey data

Analyzing non-infection-related health care utilization and health outcomes in people with type 2 diabetes during the COVID-19 pandemic: making use of individually linked statutory health insurance data and survey data - HI_T2DM_COVID

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00039740
Enrollment
11000
Registered
2026-04-22
Start date
2026-11-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

E11

Interventions

Group 1: Observational study: The study population comprises all continuously insured individuals within statutory health insurance, with and without type 2 diabetes mellitus (T2DM), aged 40 years and
self-reported cancellation or delay of health care service appointments by physicians
self-reported cancellation or delay of health care service appointments by patients
and perceived negative health consequences due to such cancellations or delays. The observation period for the survey is 2020–2023 (COVID-19 pandemic).

Sponsors

Institut für Versorgungsforschung und Gesundheitsökonomie (IVG) Deutsches Diabetes Zentrum (DDZ) Träger: Deutsche Diabetes-Forschungsgesellschaft e.V. Leibniz-Zentrum für Diabetes-Forschung an der Heinrich-Heine-Universität Düsseldorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Specific inclusion criteria (SHI population): Source population: Individuals insured with AOK Rheinland/Hamburg who were continuously insured from January 1, 2017, to March 31, 2020 (maximum gap of 30 days per year), and who were born in 1976 or earlier. T2DM group: All individuals from the source population with type 2 diabetes mellitus in 2017, identified using an established algorithm (WIdO 2025). Potential controls: All individuals from the source population without any diabetes diagnosis (no ICD-10 codes E10–E14 in any sector of care), without prescriptions for ATC A10 medications, and without participation in a disease management program (DMP; type 1 or type 2 diabetes) during the period 2017–2023. Controls (matching): 1:1 matching to T2DM cases using exact matching based on year of birth, sex, and the quarter of the last day of insurance coverage (2020–2023). Specific inclusion criteria (survey): Potential survey participants: Individuals from the T2DM group and the control group with continuous insurance coverage (maximum gap of 30 days) from January 1, 2017, up to the current time point. Sample: Random selection of n = 5,500 individuals each from the T2DM group and the control group, followed by postal invitation to participate in the study.

Exclusion criteria

Exclusion criteria: Individuals with diabetes mellitus who cannot be clearly classified as having type 2 diabetes mellitus are excluded. This includes, in particular: - Individuals with type 1 diabetes mellitus (ICD-10: E10) - Individuals with other or unspecified types of diabetes mellitus (ICD-10: E12–E14), if a clear classification as type 2 diabetes is not possible - Individuals with inconsistent or non-classifiable diabetes diagnoses (e.g., concurrent coding of multiple diabetes types without a clear assignment within the hierarchical algorithm) In addition, individuals are excluded if they are younger than 40 years of age or if they have interruptions in statutory health insurance coverage between 2017 and 2020 exceeding more than 30 days per calendar year

Design outcomes

Primary

MeasureTime frame
Health care utilization and health outcomes (based on statutory health insurance data) are assessed and compared for the periods 2018–2019 (baseline) and 2020–2023 (pandemic period). The analyses focus on health care utilization as well as changes in general and T2DM-specific health outcomes, including differences in these changes between individuals with and without type 2 diabetes mellitus. Using a questionnaire, the following aspects are assessed for the pandemic period (one-time cross-sectional survey with retrospective reporting): fear of infection or COVID-19-related long-term health consequences; self-reported cancellations or delays of health care service appointments by physicians; self-reported cancellations or delays of health care service appointments by patients; and perceived negative health consequences resulting from such cancellations or delays.

Countries

Germany

Contacts

Public ContactAndrea Icks

Institut für Versorgungsforschung und Gesundheitsökonomie (IVG) Deutsches Diabetes Zentrum (DDZ) Träger: Deutsche Diabetes-Forschungsgesellschaft e.V. Leibniz-Zentrum für Diabetes-Forschung an der Heinrich-Heine-Universität Düsseldorf

andrea.icks@ddz.de+49 211 3382-400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026