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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
personalized care plan
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Personalized care plan

Arm Description

A personalized care plan will be deployed according to patient profile/ disease characteristics

Outcomes

Primary Outcome Measures

Assessment of adherence
Percentage of patients adherent to the use of personalized care plan

Secondary Outcome Measures

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
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
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.
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
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.
Change in the estimated HbA1c from the baseline phase and post intervention
The estimated HbA1c is based on average glucose measured continuously
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
Description of Adverse events
All adverse events recorded by the investigator during the study period

Full Information

First Posted
March 20, 2023
Last Updated
July 19, 2023
Sponsor
Air Liquide Santé International
Collaborators
Key2Compliance, NordicInfu Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT05793645
Brief Title
Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
Key2Compliance, NordicInfu Care AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized care plan
Arm Type
Experimental
Arm Description
A personalized care plan will be deployed according to patient profile/ disease characteristics
Intervention Type
Device
Intervention Name(s)
personalized care plan
Intervention Description
Algorithm that defines personalized care plan
Primary Outcome Measure Information:
Title
Assessment of adherence
Description
Percentage of patients adherent to the use of personalized care plan
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Evaluation of the children satisfaction with regards to the intervention
Description
Evaluation of the children satisfaction with the intervention using a likert scale at the end of the intervention
Time Frame
15 weeks
Title
Evaluation of the parents satisfaction with regards to the intervention
Description
Evaluation of the parents satisfaction with the intervention using a likert scale at the end of the intervention
Time Frame
15 weeks
Title
Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.
Description
The total score is calculated as the mean of 27 items. Higher score represent better QoL.
Time Frame
15 weeks
Title
Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)
Description
GYPES is a validated 15 items likert scale questionnaire measured at baseline phase and post intervention
Time Frame
15 weeks
Title
Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.
Description
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.
Time Frame
15 weeks
Title
Change in the estimated HbA1c from the baseline phase and post intervention
Description
The estimated HbA1c is based on average glucose measured continuously
Time Frame
15 weeks
Title
Evolution of patient glycemic parameters from baseline to the end of intervention
Description
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
Time Frame
15 weeks
Title
Description of Adverse events
Description
All adverse events recorded by the investigator during the study period
Time Frame
Through study completion, an average of 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henry TAUPIN
Phone
+33619947113
Email
fralsi-ctpublication@airliquide.com
Facility Information:
Facility Name
Helsingborg Lasarett
City
Helsingborg
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotta NILSSON
First Name & Middle Initial & Last Name & Degree
Charlotta Nilsson
Facility Name
Sachsska, barn- och ungdomssjukhuset
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjorn Rathsman
First Name & Middle Initial & Last Name & Degree
Bjorn RATHSMAN
Facility Name
Norrlands universitetssjukhus
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Lundberg
First Name & Middle Initial & Last Name & Degree
Elena Lundberg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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