Children, Diabetes, Quality of Life
Conditions
Keywords
Diabetes, Children, Quality of Life, peer support, Play, Calmness, Group-based education
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGroup consultations and peer-to-peer learning
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.
OTHERStandard Care (in control arm)
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.
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
Inclusion of children and their families Inclusion Criteria: * Age 3-10 years * Followed at Steno Diabetes Center Copenhagen
Exclusion criteria
* Severe psychiatric disease * Language barriers (Children not speaking Danish, Parents not speaking Danish or English)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parental diabetes-related quality of life (T1DAL) | From baseline to study end after one year | 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. |
| Children's perception of clinical visits (MyHospitalVoice) | From baseline to study end after one year | 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- |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycemic outcomes by CGM-derived metrics | From baseline to study end after one year | 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. |
| Change in glycemic outcomes measured by HbA1c | From baseline to study end after one year | Hba1c in mmol/mol |
| Change in total daily dose of insulin per kg | From baseline to study end after one year | Measured as a mean value during the last 14 days |
| Change in the number of boluses registered per day | From baseline to study end after one year | registered by the insulin pump, measured as a mean value during the last 14 days |
| Change in timing of boluses | From baseline to study end after one year | Missed or late boluses registered by the insulin pump. Measured as a mean value during the last 14 days |
| Change in carbohydrates/kg entered per day | From baseline to study end after one year | Registered by the insulin pump. Measured as a mean value during the last 14 days |
| Change in infusion set wear-time | From baseline to study end after one year | Registered by the insulin pump. Measured as a mean value during the last 14 days |
| Change in time in automated insulin delivery mode (AID) on the insulin pump system. | From baseline to study end after one year | Registered by the insulin pump, in percentages of time during the last 14 days. |
| Change in conflicts and problems with procedures | From baseline to study end after one year | Change in conflicts around meals; FLACC (pain and fear scores and conflicts around painful procedures related to diabetes management) |
| Change in parental fear of hypoglycemia | From baseline to study end after one year | Change in parental fear of hypoglycemia measured by questionnaire |
| Change in BMI z-scores | From baseline to study end after one year | 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. |
| Participation in planned modules | From baseline to study end after one year | Participation pr. year pr. family out of the four held modules. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORJannet Svensson
Steno Diabetes Center Copenhagen
Outcome results
None listed