Exploring diabetes numeracy and health literacy across Europe - EDUCATE study

Exploring diabetes numeracy and health literacy across Europe - EDUCATE study - EDUCATE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57080

Enrollment

Registered

2024-11-05

Start date

2025-02-03

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Diabetes mellitus

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: To be eligible to participate in this study, a participant must meet all of the following criteria: - Time from diagnosis of type 1 (inclusief LADA) or 2 diabetes mellitus >=1 year - Age between 18 to 80 years including both age limits - On intensive insulin treatment >= 1 year - Willing and able to use the goFOODTMLite, activPAL4TM and the blinded CGM, and to complete all questionnaires. - Ability to provide informed consent

Exclusion criteria

Exclusion criteria: - Inability to understand the local language of the country where the study is conducted (at the investigator*s discretion). - Other subtypes of diabetes than type 1 or type 2 diabetes (e.g., gestational diabetes, MODY) - Severe cognitive, hearing or visual impairment preventing participants in completing the questionnaires and/or using the trial devices at the investigator*s discretion - Known hypersensitivity to the CGM sensor band-aid - Current or recent participation (within the last three months) in clinical trials/research projects (at the investigator*s discretion) - Unstable cardiovascular disease (major adverse cardiovascular event in the last 6 months), active malignancy (chemotherapy or palliation therapy in the last 6 months), kidney failure (eGFR

Design outcomes

Primary

Measure	Time frame
The main study parameter is health literacy assessed using the health literacy questionnaire (HLQ).	—

Secondary

Measure	Time frame
Secondary endpoints are numeracy skills assessed by the short version of the diabetes numeracy test (DNT-15), individuals* readiness for usage of digital health services or technology assessed by the Readiness and enablement index for Health technology (RAEADHY), healthy behaviour (dietary pattern assessed through the goFOODTMLite system and Maastricht Food Frequency Questionnaire, and physical activity assessed with the ac-tivPal4TM), and patient reported outcomes (e.g., diabetes treatment satisfaction questionnaire, problem areas in diabetes distress, etc.). Glycaemic outcomes are assessed as haemoglobin A1c and blinded FreeStyle Libre 3 continuous glucose monitoring (CGM) according to inter-national consensus for CGM outcomes for outpatients.	—

Measure

Time frame

Secondary endpoints are numeracy skills assessed by the short version of the diabetes numeracy test (DNT-15), individuals* readiness for usage of digital health services or technology assessed by the Readiness and enablement index for Health technology (RAEADHY), healthy behaviour (dietary pattern assessed through the goFOODTMLite system and Maastricht Food Frequency Questionnaire, and physical activity assessed with the ac-tivPal4TM), and patient reported outcomes (e.g., diabetes treatment satisfaction questionnaire, problem areas in diabetes distress, etc.). Glycaemic outcomes are assessed as haemoglobin A1c and blinded FreeStyle Libre 3 continuous glucose monitoring (CGM) according to inter-national consensus for CGM outcomes for outpatients.

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Countries

Netherlands

Outcome results