DiabetesStenoChildNCT07377266
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
A study testing Group consultations and peer-to-peer learning in people with Diabetes and Quality of Life, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Diabetes, Quality of Life, Children
- What is being tested?
- Group consultations and peer-to-peer learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-10 years
- Followed at Steno Diabetes Center Copenhagen
Who cannot join
- Severe psychiatric disease
- Language barriers (Children not speaking Danish, Parents not speaking Danish or English)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Diabetes, Quality of Life, Children
- Being tested
- Group consultations and peer-to-peer learning, Standard Care (in control arm)
- Keywords
- Diabetes, Children, Quality of Life, peer support, Play, Calmness, Group-based education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group consultations and peer-to-peer learningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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-
Measured: From baseline to study end after one year
Secondary outcomes (12)
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.
Measured: From baseline to study end after one year
Change in glycemic outcomes measured by HbA1c
Hba1c in mmol/mol
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: From baseline to study end after one year
Change in parental fear of hypoglycemia
Change in parental fear of hypoglycemia measured by questionnaire
Measured: 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.
Measured: From baseline to study end after one year
Participation in planned modules
Participation pr. year pr. family out of the four held modules.
Measured: From baseline to study end after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanna Lind, Steno Diabetes Center Copenhagen
- Investigators
- Jannet Svensson, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377266
- Sponsor's protocol ID
- H-25016032
- Other IDs
- p-2024-17600
- Acronym
- StenoChild
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07377266
- Acronym / sponsor ID
- StenoChild / H-25016032
- Conditions
- Diabetes, Quality of Life, Children
- Keywords
- Diabetes, Children, Quality of Life, peer support, Play, Calmness, Group-based education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StenoChild intervention | Experimental | Behavioral: Group consultations and peer-to-peer learningSee 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. |
| Standard Care | Placebo comparator | Other: Standard Care (in control arm)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. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 3-10 years
- Followed at Steno Diabetes Center Copenhagen
Key exclusion criteria (2 listed)
- Severe psychiatric disease
- Language barriers (Children not speaking Danish, Parents not speaking Danish or English)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group consultations and peer-to-peer learningThe 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. | Behavioural | StenoChild intervention |
| 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. | Other | Standard Care |
Primary outcome
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.
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-
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jannet Svensson principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group consultations and peer-to-peer learning in people with Diabetes and Quality of Life, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental diabetes-related quality of life (T1DAL) (time frame: From baseline to study end after one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.