Type 1 DiabetesODINNCT05793645
Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program
A study testing personalized care plan in people with Type 1 Diabetes, run by Air Liquide Santé International at 3 sites in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- personalized care plan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSweden
- Study dates
- 15 May 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Not yet recruiting
Helsingborg Lasarett
Helsingborg
Charlotta NILSSON
Charlotta Nilsson
- Recruiting
Sachsska, barn- och ungdomssjukhuset
Stockholm
Bjorn Rathsman
Bjorn RATHSMAN
- Recruiting
Norrlands universitetssjukhus
Umeå
Elena Lundberg
Elena Lundberg
About this study
Official title: 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
- Conditions
- Type 1 Diabetes
- Being tested
- personalized care plan
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized care planDevice
Algorithm that defines personalized care plan
| Study group | Role | What they receive |
|---|---|---|
| Personalized care plan | Experimental | A personalized care plan will be deployed according to patient profile/ disease characteristics Receives: Device: personalized care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adherence
Percentage of patients adherent to the use of personalized care plan
Measured: 15 weeks
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 15 weeks
Change in the estimated HbA1c from the baseline phase and post intervention
The estimated HbA1c is based on average glucose measured continuously
Measured: 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
Measured: 15 weeks
Description of Adverse events
All adverse events recorded by the investigator during the study period
Measured: Through study completion, an average of 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start15 May 2023
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, NordicInfu Care AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793645
- Sponsor's protocol ID
- ALMED-22-002
- Acronym
- ODIN
- Status last verified
- Jul 2023
- First submitted
- 20 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program, the dALi System, for Pediatric Type 1 Diabetes (T1D) Subjects
- ClinicalTrials.gov ID
- NCT05793645
- Acronym / sponsor ID
- ODIN / ALMED-22-002
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Key2Compliance, NordicInfu Care AB
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized care plan | Experimental | Device: personalized care planA personalized care plan will be deployed according to patient profile/ disease characteristics |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized care planAlgorithm that defines personalized care plan | Device | Personalized care plan |
Primary outcome
Assessment of adherence
Time frame: 15 weeks
Percentage of patients adherent to the use of personalized care plan
8 secondary outcomes
Evaluation of the children satisfaction with regards to the intervention
Time frame: 15 weeks
Evaluation of the parents satisfaction with regards to the intervention
Time frame: 15 weeks
Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.
Time frame: 15 weeks
Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)
Time frame: 15 weeks
Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.
Time frame: 15 weeks
Change in the estimated HbA1c from the baseline phase and post intervention
Time frame: 15 weeks
Evolution of patient glycemic parameters from baseline to the end of intervention
Time frame: 15 weeks
Description of Adverse events
Time frame: Through study completion, an average of 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized care plan in people with Type 1 Diabetes, run by Air Liquide Santé International at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry TAUPIN (+33619947113, fralsi-ctpublication@airliquide.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adherence (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.