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

NCT05793645 | Unknown

• 1 other identifier: ALMED-22-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Assessment of adherence

  Percentage of patients adherent to the use of personalized care plan

  15 weeks

Secondary Outcomes (8)

• Evaluation of the children satisfaction with regards to the intervention

  15 weeks

• Evaluation of the parents satisfaction with regards to the intervention

  15 weeks

• Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.

  15 weeks

• Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)

  15 weeks

• Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.

  15 weeks

Study Arms (1)

Personalized care plan

EXPERIMENTAL

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

Device: personalized care plan

Interventions

personalized care plan DEVICE

Algorithm that defines personalized care plan

Personalized care plan

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Liquide Santé International: lead
• Key2Compliance: collaborator
• NordicInfu Care AB: collaborator

Study Sites (3)

Helsingborg Lasarett

Helsingborg, Sweden

NOT YET RECRUITING

Sachsska, barn- och ungdomssjukhuset

Stockholm, Sweden

RECRUITING

Norrlands universitetssjukhus

Umeå, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Henry TAUPIN

CONTACT

+33619947113; fralsi-ctpublication@airliquide.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: May 15, 2023
• Primary Completion: January 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

SE (3)