Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program (ODIN)
Type 1 Diabetes
About this trial
This is an interventional health services research trial for 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.
Sites / Locations
- Helsingborg Lasarett
- Sachsska, barn- och ungdomssjukhusetRecruiting
- Norrlands universitetssjukhusRecruiting
Arms of the Study
Arm 1
Experimental
Personalized care plan
A personalized care plan will be deployed according to patient profile/ disease characteristics