The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.
The investigators encourage families to engage in eating, exercising, playing, and storytelling together, leveraging children's natural inclination to learn through play. This approach allows healthcare providers (HCPs) and parents to gain insights into the child's perspective, improving communication. The hypotheses are i) improved calmness during diabetes-related tasks with potential painful procedures such as shift of insulin infusions set and sensor will ease diabetes management and reduce parental distress; ii) improved structure and calmness around meals will ease diabetes management, reflected in interaction with insulin pumps; iii) the group and play-based approach will lead to healthier lifestyle changes compared to usual care.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The intervention introduces strategies to promote structured meals, calmness, and balanced diabetes self-management using play and storytelling learning strategies. Families participate in interactive modules in small groups (\~6-8 families), covering topics like "Meal Calmness" and "Calm Mind" four times during a year (every third month). Parents learn practical techniques to reduce conflict and improve dialogue around diabetes management. Children under 7 receive play-based sessions; those 7 and older receive story-based sessions. Clinical data as well as questionnaires will be collected at each session.
The control group receives standard care, with the intervention offered later in a waitlist design. Clinical data as well as questionnaires will be collected at baseline and again after one year.
Steno Diabetes Center Copenhagen
Herlev, Denmark
Parental diabetes-related quality of life (T1DAL)
Change in Parental diabetes-related quality of life, measured by the questionnaire T1DAL in Danish. An increase in score indicates an improvement in parental diabetes-related quality of life.
Time frame: From baseline to study end after one year
Children's perception of clinical visits (MyHospitalVoice)
Change in Children's perception of clinical visits, measured by the questionnaire MyHospitalVoice in Danish. An increase in score indicates an improvement in perception of clinical visits-
Time frame: From baseline to study end after one year
Change in glycemic outcomes by CGM-derived metrics
Time in range (glucose levels 3.9-10 mmol/l), time above range (\>10 mmol/l), time below range (\<3.9 mmol/l), in percentages of time, measured over the last 14 days.
Time frame: From baseline to study end after one year
Change in glycemic outcomes measured by HbA1c
Hba1c in mmol/mol
Time frame: From baseline to study end after one year
Change in total daily dose of insulin per kg
Measured as a mean value during the last 14 days
Time frame: From baseline to study end after one year
Change in the number of boluses registered per day
registered by the insulin pump, measured as a mean value during the last 14 days
Time frame: From baseline to study end after one year
Change in timing of boluses
Missed or late boluses registered by the insulin pump. Measured as a mean value during the last 14 days
Time frame: From baseline to study end after one year
Change in carbohydrates/kg entered per day
Registered by the insulin pump. Measured as a mean value during the last 14 days
Time frame: From baseline to study end after one year
Change in infusion set wear-time
Registered by the insulin pump. Measured as a mean value during the last 14 days
Time frame: From baseline to study end after one year
Change in time in automated insulin delivery mode (AID) on the insulin pump system.
Registered by the insulin pump, in percentages of time during the last 14 days.
Time frame: From baseline to study end after one year
Change in conflicts and problems with procedures
Change in conflicts around meals; FLACC (pain and fear scores and conflicts around painful procedures related to diabetes management)
Time frame: From baseline to study end after one year
Change in parental fear of hypoglycemia
Change in parental fear of hypoglycemia measured by questionnaire
Time frame: From baseline to study end after one year
Change in BMI z-scores
Age, sex, weight, and height will be used to report BMI z-scores for children by using WHO definitions for children in the age; 0-5 and 5-10 years.
Time frame: From baseline to study end after one year
Participation in planned modules
Participation pr. year pr. family out of the four held modules.
Time frame: From baseline to study end after one year
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