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

July 19, 2023 updated by: Air Liquide Santé International

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of adherence
Time Frame: 15 weeks
Percentage of patients adherent to the use of personalized care plan
15 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the children satisfaction with regards to the intervention
Time Frame: 15 weeks
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
Time Frame: 15 weeks
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.
Time Frame: 15 weeks
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)
Time Frame: 15 weeks
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.
Time Frame: 15 weeks
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
Time Frame: 15 weeks
The estimated HbA1c is based on average glucose measured continuously
15 weeks
Evolution of patient glycemic parameters from baseline to the end of intervention
Time Frame: 15 weeks
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
Time Frame: Through study completion, an average of 15 weeks
All adverse events recorded by the investigator during the study period
Through study completion, an average of 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Liquide Santé International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Key2Compliance
NordicInfu Care AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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