Clinical trial NCT05793645: Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program
Official title: Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program, the dALi System, for Pediatric Type 1 Diabetes (T1D) Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Key2Compliance
name: NordicInfu Care AB
First posted: 2023-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this interventional study is to assess the adherence to a personalized care plan in patients (12-15 years) with Type 1 diabetes


Eligibility criteria: Inclusion Criteria:

* Male or female, 12-15 years of age.
* T1D diagnosis minimum 8 months prior to the Screening/Initiation visit (Visit 0).
* Equipped with Continuous Glucose Monitoring (CGM) System, intermittent or real-time, either alone or associated with an insulin pump system
* Subject and health care provider must use a Remote diabetes management platform for the upload and follow-up of CGM, pump data or HCL data (e.g.: Glooko, Diasend).
* Parent or guardian able and willing to give informed consent for the subject's participation in the investigation.

Exclusion Criteria:

* Initiation of use of HCL System during the last 2 months or during the investigation.
* Use of Medtronic insulin pump.
* Any disease or other medical condition, prior or concomitant medication /treatment

  /intervention, that may affect this clinical investigation or in other ways make the subject unsuitable for participation in this investigation, according to the judgement of the Principal Investigator (PI), or authorized designee.
* Participation in any clinical investigation or study within the previous 30 days, that may affect the safety or performance of this investigation.
* Mental incapacity precluding understanding or cooperation.
* Subject not able to read and communicate in Swedish without an interpreter.

Primary outcomes:
measure: Assessment of adherence
timeFrame: 15 weeks
Secondary outcomes:
measure: Evaluation of the children satisfaction with regards to the intervention
timeFrame: 15 weeks
measure: Evaluation of the parents satisfaction with regards to the intervention
timeFrame: 15 weeks
measure: Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.
timeFrame: 15 weeks
measure: Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)
timeFrame: 15 weeks
measure: Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.
timeFrame: 15 weeks
measure: Change in the estimated HbA1c from the baseline phase and post intervention
timeFrame: 15 weeks
measure: Evolution of patient glycemic parameters from baseline to the end of intervention
timeFrame: 15 weeks
measure: Description of Adverse events
timeFrame: Through study completion, an average of 15 weeks
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg Lasarett
city: Stockholm
country: Sweden
facility: Sachsska, barn- och ungdomssjukhuset
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
Study officials:
References: