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Effects of the use of the final PAL System release on Type 1 Diabetes Mellitus self-management determinants in children aged 7-14

Effects of the use of the final PAL System release on Type 1 Diabetes Mellitus self-management determinants in children aged 7-14 - Effect of PAL on self-management in children with T1DM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46455
Enrollment
50
Registered
2018-08-20
Start date
2018-09-03
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Insulin-dependent diabetes type I diabetes

Interventions

The children meet the robot in the hospital and play an educational activity. Also, they set with their HCP and parents personal diabetes self-management objectives, to work on at home through their

Sponsors

TNO
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)