Type1diabetesNCT06372392
Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps
A study testing Universal meal coefficient utilization in people with Type1diabetes, run by Tartu University Hospital at 1 site in Estonia.
Trial summary
Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport. Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Universal meal coefficient utilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEstonia
- Study dates
- 10 Oct 2023to 1 Dec 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 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 7-19
- type 1 diabetes diagnosed at least 1 year ago
- insulin in the dose 0,5-1,0 units/day/kg
- MiniMed 780G pump usage at least 1 month.
Who cannot join
- Active coeliac disease
- Chronic disease possible to influence diabetes treatment
- Acute disease at the moment of recruitment
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
TartuUH
Tartu, Tartu, 50406
Aleksandr Peet, 5532256, aleksandr.peet@kliinikum.ee
About this study
Official title: Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps
Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.
- Conditions
- Type1diabetes
- Being tested
- Universal meal coefficient utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal meal coefficient utilizationDevice
Usage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps
| Study group | Role | What they receive |
|---|---|---|
| Universal coefficient | Experimental | With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals) Receives: Device: Universal meal coefficient utilization |
| Individualized coefficient | Active comparator | With meal bolus coefficient individualized according to physician judgment's Receives: Device: Universal meal coefficient utilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR)
Comparision of TIR between groups
Measured: 4 weeks
Secondary outcomes (4)
TBR
Comparision of TBR between groups
Measured: 4 weeks
TAR
Comparision of TAR between groups
Measured: 4 weeks
auto-corrections %
auto-corrections % between groups
Measured: 4 weeks
coefficient of variability
coefficient of variability between groups
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start10 Oct 2023
- Primary completion10 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Estonia Research Council
- Responsible party
- Principal investigator, Aleksandr Peet, Tartu University Hospital
- Investigators
- Aleksandr Peet, Principal investigator, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372392
- Sponsor's protocol ID
- 1.0
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps
- ClinicalTrials.gov ID
- NCT06372392
- Acronym / sponsor ID
- 1.0
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- Estonia Research Council
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Apr 2024 (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.
Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal coefficient | Experimental | Device: Universal meal coefficient utilizationWith fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals) |
| Individualized coefficient | Active comparator | Device: Universal meal coefficient utilizationWith meal bolus coefficient individualized according to physician judgment's |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 7-19
- type 1 diabetes diagnosed at least 1 year ago
- insulin in the dose 0,5-1,0 units/day/kg
- MiniMed 780G pump usage at least 1 month.
Key exclusion criteria (3 listed)
- Active coeliac disease
- Chronic disease possible to influence diabetes treatment
- Acute disease at the moment of recruitment
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 |
|---|---|---|
| Universal meal coefficient utilizationUsage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps | Device | Individualized coefficient, Universal coefficient |
Primary outcome
Time in range (TIR)
Time frame: 4 weeks
Comparision of TIR between groups
4 secondary outcomes
TBR
Time frame: 4 weeks
TAR
Time frame: 4 weeks
auto-corrections %
Time frame: 4 weeks
coefficient of variability
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Aleksandr Peet principal investigator
Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal meal coefficient utilization in people with Type1diabetes, run by Tartu University Hospital at 1 site in Estonia.
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 4 inclusion and 3 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. 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 Aleksandr Peet, MD, PhD (5532256, aleksandr.peet@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) (time frame: 4 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 18 Apr 2024.