Type 1 DiabetesNCT04668612
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
A study testing Dual-bolus and Standard bolus in people with Type 1 Diabetes, run by Tartu University Hospital at 1 site in Estonia.
Trial summary
To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Dual-bolus and Standard bolus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEstonia
- Study dates
- 4 Sep 2020to 30 Jun 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
- Insulin pump and CGM initiated at least 3 months prior to the recruitment.
- Estimated HbA1c based on the 14-days CGM report above 8.5%.
- Daily insulin dose of more than 0.5 international units per kilogram.
Who cannot join
- Subjects with known diabetes complications.
- Elevated tissue transglutaminase IgA antibodies in the last two years.
- Children who developed an acute viral infections during the week preceding the recruitment.
- Basal insulin proportion > 55% of daily insulin dose.
- Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
- Estimated HbA1c > 8.5% based on the 14-days CGM report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Read the detailed description
Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.
Trial population A total of 30 subjects with type 1 diabetes.
- Conditions
- Type 1 Diabetes
- Being tested
- Dual-bolus, Standard bolus
- 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.
Dual-bolusDevice
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
Standard bolusDevice
Standard boluses for all meals
| Study group | Role | What they receive |
|---|---|---|
| Standard-bolus | Active comparator | Standard boluses for all meal Receives: Device: Standard bolus |
| Dual-bolus | Experimental | Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m Receives: Device: Dual-bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.
Measured: 14 days
Secondary outcomes (2)
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (<3,9 mmol/L)
Measured: 14 days
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (>10.0 mmol/L)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start4 Sep 2020
- Primary completion20 May 2021 (estimated)
- Study completion30 Jun 2021 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized open-label single-center crossover clinical study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian Research Council
- Responsible party
- Principal investigator, Aleksandr Peet, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668612
- Sponsor's protocol ID
- 1.1
- Status last verified
- Mar 2021
- First submitted
- 30 Nov 2020
- Last updated
- 1 Apr 2021
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04668612
- Acronym / sponsor ID
- 1.1
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- Estonian Research Council
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 16 Dec 2020 (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.
To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Detailed description
Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.
Trial population A total of 30 subjects with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized open-label single-center crossover clinical study
| Arm | Type | Receives |
|---|---|---|
| Standard-bolus | Active comparator | Device: Standard bolusStandard boluses for all meal |
| Dual-bolus | Experimental | Device: Dual-bolusDual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
- Insulin pump and CGM initiated at least 3 months prior to the recruitment.
- Estimated HbA1c based on the 14-days CGM report above 8.5%.
- Daily insulin dose of more than 0.5 international units per kilogram.
Key exclusion criteria (6 listed)
- Subjects with known diabetes complications.
- Elevated tissue transglutaminase IgA antibodies in the last two years.
- Children who developed an acute viral infections during the week preceding the recruitment.
- Basal insulin proportion > 55% of daily insulin dose.
- Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
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 |
|---|---|---|
| Dual-bolusDual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m. | Device | Dual-bolus |
| Standard bolusStandard boluses for all meals | Device | Standard-bolus |
Primary outcome
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Time frame: 14 days
To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.
2 secondary outcomes
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Time frame: 14 days
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-bolus and Standard bolus in people with Type 1 Diabetes, 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 6 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 1 Apr 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. (time frame: 14 days). 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 1 Apr 2021.