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

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: personalized care plan

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henry TAUPIN; Phone Number: +33619947113; Email: fralsi-ctpublication@airliquide.com

Study Locations

• Sweden
  • Helsingborg, Sweden
    • Not yet recruiting
    • Helsingborg Lasarett
    • Contact: Charlotta NILSSON
    • Principal Investigator: Charlotta Nilsson
  • Stockholm, Sweden
    • Recruiting
    • Sachsska, barn- och ungdomssjukhuset
    • Contact: Bjorn Rathsman
    • Principal Investigator: Bjorn RATHSMAN
  • Umeå, Sweden
    • Recruiting
    • Norrlands Universitetssjukhus
    • Contact: Elena Lundberg
    • Principal Investigator: Elena Lundberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized care plan; A personalized care plan will be deployed according to patient profile/ disease characteristics	Device: personalized care plan; Algorithm that defines personalized care plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adherence	Percentage of patients adherent to the use of personalized care plan	15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change in the estimated HbA1c from the baseline phase and post intervention	The estimated HbA1c is based on average glucose measured continuously	15 weeks
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
Description of Adverse events	All adverse events recorded by the investigator during the study period	Through study completion, an average of 15 weeks

Collaborators and Investigators

• Sponsor: Air Liquide Santé International
• Collaborators: Key2Compliance; NordicInfu Care AB

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ALMED-22-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No