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 (StenoChild)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Diabetes; Children
• Intervention / Treatment: Behavioral: Group consultations and peer-to-peer learning; Other: Standard Care (in control arm)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Steno Diabetes Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StenoChild intervention; 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.	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 and older receive story-based sessions. Clinical data as well as questionnaires will be collected at each session.
Placebo Comparator: Standard Care; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Jannet Svensson, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Quality of Life; Children; peer support; Calmness; Play; Group-based education
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: H-25016032; p-2024-17600 (Other Identifier: Danish Data Protection Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No