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

Type 1 Diabetes Clinical Trial

— ODIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793645
• Other study ID #: ALMED-22-002
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: July 2023
• Source: Air Liquide Santé International
• Contact: Henry TAUPIN
• Phone: +33619947113
• Email: fralsi-ctpublication[@]airliquide.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• personalized care plan
Algorithm that defines personalized care plan

Locations

Country	Name	City	State
Sweden	Helsingborg Lasarett	Helsingborg
Sweden	Sachsska, barn- och ungdomssjukhuset	Stockholm
Sweden	Norrlands universitetssjukhus	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Air Liquide Santé International	Key2Compliance, NordicInfu Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adherence	Percentage of patients adherent to the use of personalized care plan	15 weeks
Secondary	Evaluation of the children satisfaction with regards to the intervention	Evaluation of the children satisfaction with the intervention using a likert scale at the end of the intervention	15 weeks
Secondary	Evaluation of the parents satisfaction with regards to the intervention	Evaluation of the parents satisfaction with the intervention using a likert scale at the end of the intervention	15 weeks
Secondary	Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.	The total score is calculated as the mean of 27 items. Higher score represent better QoL.	15 weeks
Secondary	Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)	GYPES is a validated 15 items likert scale questionnaire measured at baseline phase and post intervention	15 weeks
Secondary	Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.	The PedsQL Diabetes Module (PedsQL) is a validated 28-items likert scale questionnaire designed to assess diabetes-specific Helath Related Quality of Life children and adolescents. It contains questions related to diabetes management.	15 weeks
Secondary	Change in the estimated HbA1c from the baseline phase and post intervention	The estimated HbA1c is based on average glucose measured continuously	15 weeks
Secondary	Evolution of patient glycemic parameters from baseline to the end of intervention	Glycemic parameters measured are the Time in Range (TIR), the Time Above Range (TAR) and the Time Below Range (TBR). TIR, TAR and TBR refer to the percentage of CGM readings and time per day within, above and below the target glucose range	15 weeks
Secondary	Description of Adverse events	All adverse events recorded by the investigator during the study period	Through study completion, an average of 15 weeks