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| ID | Type | Description | Link |
|---|---|---|---|
| p-2024-17600 | Other Identifier | Danish Data Protection Agency |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| StenoChild intervention | Experimental | See below, Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design. |
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| Standard Care | Placebo Comparator | Families are randomized pragmatically based on their assigned HCP. Approximately 50% will attend a new clinic offering group-based, family-centered care (90-100 families); the rest receive standard care, with the intervention offered later in a waitlist design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group consultations and peer-to-peer learning | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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- | From baseline to study end after one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to study end after one year |
| Change in glycemic outcomes measured by HbA1c |
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Inclusion of children and their families
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jannet Svensson | Steno Diabetes Center Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
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| Standard Care (in control arm) | Other | 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. |
|
Hba1c in mmol/mol |
| 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 | 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 | 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 | 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 | 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 | 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. | 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) | From baseline to study end after one year |
| Change in parental fear of hypoglycemia | Change in parental fear of hypoglycemia measured by questionnaire | 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. | From baseline to study end after one year |
| Participation in planned modules | Participation pr. year pr. family out of the four held modules. | From baseline to study end after one year |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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