The goal of this interventional study is to assess the adherence to a personalized care plan in patients (12-15 years) with Type 1 diabetes
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
60
Algorithm that defines personalized care plan
Helsingborg Lasarett
Helsingborg, Sweden
NOT_YET_RECRUITINGSachsska, barn- och ungdomssjukhuset
Stockholm, Sweden
RECRUITINGNorrlands universitetssjukhus
Umeå, Sweden
RECRUITINGAssessment of adherence
Percentage of patients adherent to the use of personalized care plan
Time frame: 15 weeks
Evaluation of the children satisfaction with regards to the intervention
Evaluation of the children satisfaction with the intervention using a likert scale at the end of the intervention
Time frame: 15 weeks
Evaluation of the parents satisfaction with regards to the intervention
Evaluation of the parents satisfaction with the intervention using a likert scale at the end of the intervention
Time frame: 15 weeks
Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.
The total score is calculated as the mean of 27 items. Higher score represent better QoL.
Time frame: 15 weeks
Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)
GYPES is a validated 15 items likert scale questionnaire measured at baseline phase and post intervention
Time frame: 15 weeks
Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.
The PedsQL Diabetes Module (PedsQL) is a validated 28-items likert scale questionnaire designed to assess diabetes-specific Helath Related Quality of Life children and adolescents. It contains questions related to diabetes management.
Time frame: 15 weeks
Change in the estimated HbA1c from the baseline phase and post intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The estimated HbA1c is based on average glucose measured continuously
Time frame: 15 weeks
Evolution of patient glycemic parameters from baseline to the end of intervention
Glycemic parameters measured are the Time in Range (TIR), the Time Above Range (TAR) and the Time Below Range (TBR). TIR, TAR and TBR refer to the percentage of CGM readings and time per day within, above and below the target glucose range
Time frame: 15 weeks
Description of Adverse events
All adverse events recorded by the investigator during the study period
Time frame: Through study completion, an average of 15 weeks