Insulin-dependent diabetes type I diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Children should be between 7 and 14 years old - Diagnosed with type I Diabetes Mellitus (T1DM) - The diagnosis is older than six months - The child is treated at one of the participating hospitals - The child and at least one parent have a good command of the Dutch language - An informed consent form should be signed by the child and both his/her parents
Exclusion criteria
Exclusion criteria: The participant will be excluded if he/she has an co-existing medical condition that, according to the treating physician, is expected to interfere with the study results. For example intellectual disability, autism spectrum disorders, epilepsy and cerebral palsy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hypothesized main study outcomes are (1) an improvement in the intervention group in Type 1 Diabetes health outcomes: HbA1c values (measured with a finger prick) and glucose values (collected by a glucometer, as part of the standard diabetes management regime) of PAL 3.0 during phase 1. And (2) an improvement of diabetes knowledge (questionnaire). | — |
Secondary
| Measure | Time frame |
|---|---|
| The hypothesized secondary outcomes during phase 1 are (1) improvements in Diabetes-related Quality of Life (measured with the PedsQoL-DM questionnaire by both child and parent(s)), (2) self-management determinants and behaviour (measured with the Self-Care Inventory, SC, questionnaire and self-management goal achievement in the PAL-system), and (3) system usability (SUS, only intervention group). The expected outcome in phase 2 is a further improvement of the usability and use of the PAL-System V3.5, with additional features, in comparison to V3.0. | — |
Countries
Netherlands