The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group consultations and peer-to-peer learning, Standard Care (in control arm).
- Who it may be relevant to
- Registry conditions: Diabetes, Quality of Life, Children. Basic parameters: 3 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Group 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 - Other Standard 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.
Primary outcome measures
- Parental diabetes-related quality of life (T1DAL) [Time frame: From baseline to study end after one year]
- Children's perception of clinical visits (MyHospitalVoice) [Time frame: From baseline to study end after one year]
Secondary outcome measures (12)
- Change in glycemic outcomes by CGM-derived metrics [Time frame: From baseline to study end after one year]
- Change in glycemic outcomes measured by HbA1c [Time frame: From baseline to study end after one year]
- Change in total daily dose of insulin per kg [Time frame: From baseline to study end after one year]
- Change in the number of boluses registered per day [Time frame: From baseline to study end after one year]
- Change in timing of boluses [Time frame: From baseline to study end after one year]
- Change in carbohydrates/kg entered per day [Time frame: From baseline to study end after one year]
- Change in infusion set wear-time [Time frame: From baseline to study end after one year]
- Change in time in automated insulin delivery mode (AID) on the insulin pump system. [Time frame: From baseline to study end after one year]
- Change in conflicts and problems with procedures [Time frame: From baseline to study end after one year]
- Change in parental fear of hypoglycemia [Time frame: From baseline to study end after one year]
- Change in BMI z-scores [Time frame: From baseline to study end after one year]
- Participation in planned modules [Time frame: From baseline to study end after one year]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Steno Diabetes Center Copenhagen — Herlev
Identifiers
NCT: NCT07377266 · H-25016032 · p-2024-17600