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

NCT07377266 | Enrolling By Invitation

• 2 other identifiers: H-25016032p-2024-17600
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Quality of Life; Children

Keywords

Diabetes; Children; Quality of Life; peer support; Play; Calmness; Group-based education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change in glycemic outcomes by CGM-derived metrics

  From baseline to study end after one year

• Change in glycemic outcomes measured by HbA1c

  From baseline to study end after one year

• Change in total daily dose of insulin per kg

  From baseline to study end after one year

• Change in the number of boluses registered per day

  From baseline to study end after one year

• Change in timing of boluses

  From baseline to study end after one year

Study Arms (2)

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.

Behavioral: Group consultations and peer-to-peer learning

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.

Other: Standard Care (in control arm)

Interventions

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.

StenoChild intervention

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.

Standard Care

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3-10 years
• Followed at Steno Diabetes Center Copenhagen

You may not qualify if:

• Severe psychiatric disease
• Language barriers (Children not speaking Danish, Parents not speaking Danish or English)

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jannet Svensson

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral researcher, PhD, RN

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 29, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)