Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program

Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program, the dALi System, for Pediatric Type 1 Diabetes (T1D) Subjects

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

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.