Diabetes mellitus, Type 1
Conditions
Interventions
Current interventions as of 05/06/2025:
In the intervention arm, participants undertake a 6-month digital self-management intervention featuring 57 short educational videos covering topics such as: ge
Sponsors
University of Applied Sciences and Arts Western Switzerland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/06/2025: 1. Written and signed informed consent 2. Aged =18 years 3. Diagnosed with diabetes type 1 or type 2 4. French- or German-speaking (with sufficient comprehension to participate in focus groups and complete questionnaires) 5. No current or planned attendance at any other structured diabetes education initiative 6. Being interested and accustomed to the use of technology (e.g., smartphone, tablets and internet) Previous inclusion criteria: 1. Aged =18 years 2. Diagnosed with diabetes type 1 or type 2 3. No current or planned attendance at any other structured diabetes education initiative 4. Being interested and accustomed to the use of technology
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/06/2025: 1. Severe physical/mental illness 2. Significant learning difficulties 3. Unable to give informed consent 4. Relatives of the study team (spouse, children, parents or siblings) Previous exclusion criteria: 1. Severe physical/mental illness 2. Significant learning difficulties 3. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 05/06/2025: 1. Recruitment rate is measured using the proportion of eligible participants who consent to participate. Data sourced from the study recruitment log at baseline 2. Completion rate is measured using the proportion of participants who complete the intervention and follow-up assessments. Data recorded in the study database at 6 and 12 months 3. Acceptability of the intervention is measured using a participant feedback questionnaire developed based on the Technology Acceptance Model (TAM), covering perceived usefulness, ease of use, attitude toward use, and intention to use at 6 and 12 months 4. Usability of the intervention is measured using the same TAM-based participant feedback questionnaire, including Likert-scale items on orientation, clarity, and overall system satisfaction at 6 and 12 months Previous primary outcome measures: Feasibility outcomes: 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 6 months 2. Retention/attrition rates recorded as the number of participants remaining in the study at 0, 6 and 12 months 3. Adherence to data collection plan recorded as the percentage of completed study measures 4. Adherence to the intervention recorded as the number of recommended and participants’ actual use of the virtual intervention 5. Participants perceived acceptability recorded as the level of appropriateness and usefulness of the intervention using questionnaires and interviews Primary clinical outcome: 6. HbA1c recorded as the number of patients achieving HbA1c values in the set target range and the mean differences between groups at 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/06/2025: 1. Glycaemic control is measured using self-reported HbA1c values, verified with patient medical records, at baseline, 6 and 12 months 2. Diabetes self-efficacy is measured using the Diabetes Management Self-Efficacy Scale (CDSES) at baseline, 6 and 12 months 3. Chronic illness care experience is measured using the Patient Assessment of Chronic Illness Care (PACIC) questionnaire at baseline, 6 and 12 months 4. Diabetes-related emotional distress is measured using the Problem Areas in Diabetes Scale (PAID) at baseline, 6 and 12 months 5. Socioeconomic deprivation is measured using the Deprivation in Primary Care Questionnaire (DiPCare-Q) at baseline, 6 and 12 months 6. Digital health literacy is measured using the eHealth Literacy Scale (eHEALS) at baseline, 6 and 12 months. 7. General health literacy is measured using the European Health Literacy Survey Questionnaire (HLS-EU-Q) at baseline, 6 and 12 months 8. Diabetes self-management behaviors are measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire at baseline, 6 and 12 months 9. Emergency treatment events are measured as the number of emergency treatment episodes (severe hypoglycaemia, diabetic ketoacidosis, unplanned hospitalisation) based on patient records at baseline, 6 and 12 months Previous secondary outcome measures: 1. Self-efficacy measured using the Chronic Disease Self-Efficacy Scales (CDSES) at baseline, 6 and 12 months 2. Self-care management behaviour measured using the Summary of Diabetes Self-Care Activities (SDSCA) at baseline, 6 and 12 months 3. Diabetes-related emotional distress measured using the Problem Areas in Diabetes Scale (PAID) at baseline, 6 and 12 months 4. Patient reports of received care measured using Patient-Assessed Chronic Illness Care (PACIC) at baseline, 6 and 12 months 5. Health literacy measured using the European Health Literacy Survey Questionnaire (HLS-EU-Q) at baseline, 6 and 12 months 6. | — |
Countries
Switzerland
Contacts
Public ContactClaudia Huber
Outcome results
None listed