Clinical Investigation to Assess the Feasibility of a New... | NCT05793645

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

NCT05793645

Sponsor

Air Liquide Santé International

Status

Unknown status

Last Update Posted

Jul 20, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

personalized care plan

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

Jan 30, 2024Estimated

Completion Date

Mar 30, 2024Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Mar 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2023

Last Update Posted Date

Jul 20, 2023Actual

Name	Class
Key2Compliance	INDUSTRY
NordicInfu Care AB	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Personalized care plan	Experimental	A personalized care plan will be deployed according to patient profile/ disease characteristics	Device: personalized care plan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
personalized care plan	Device	Algorithm that defines personalized care plan	Personalized care plan

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Sep 10, 2025
Reset	Sep 29, 2025

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases