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Enrolling by Invitation

NCT Number: NCT07377266

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

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.

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Key information

Conditions

Diabetes Children Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Parental diabetes-related quality of life (T1DAL)

    Time frame: 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.

  2. Children's perception of clinical visits (MyHospitalVoice)

    Time frame: 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 outcomes

  1. Change in glycemic outcomes by CGM-derived metrics

    Time frame: 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.

  2. Change in glycemic outcomes measured by HbA1c

    Time frame: From baseline to study end after one year

    Hba1c in mmol/mol

  3. Change in total daily dose of insulin per kg

    Time frame: From baseline to study end after one year

    Measured as a mean value during the last 14 days

  4. Change in the number of boluses registered per day

    Time frame: From baseline to study end after one year

    registered by the insulin pump, measured as a mean value during the last 14 days

  5. Change in timing of boluses

    Time frame: 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

  6. Change in carbohydrates/kg entered per day

    Time frame: From baseline to study end after one year

    Registered by the insulin pump. Measured as a mean value during the last 14 days

  7. Change in infusion set wear-time

    Time frame: From baseline to study end after one year

    Registered by the insulin pump. Measured as a mean value during the last 14 days

  8. Change in time in automated insulin delivery mode (AID) on the insulin pump system.

    Time frame: From baseline to study end after one year

    Registered by the insulin pump, in percentages of time during the last 14 days.

  9. Change in conflicts and problems with procedures

    Time frame: 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)

  10. Change in parental fear of hypoglycemia

    Time frame: From baseline to study end after one year

    Change in parental fear of hypoglycemia measured by questionnaire

  11. Change in BMI z-scores

    Time frame: 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.

  12. Participation in planned modules

    Time frame: From baseline to study end after one year

    Participation pr. year pr. family out of the four held modules.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Acronym: StenoChild

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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