Type 1 DiabetesNCT04558710
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
An observational study of Type 1 Diabetes and Continuous Glucose Monitoring, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
Trial summary
The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Type 1 Diabetes, Continuous Glucose Monitoring, Children
- How many people
- 339 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2018to 30 Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and treated with insulin pump fo at least 3 months.
Who may be able to join
- Age below 7 years of age (at inclusion)
- Type 1 diabetes for at least 6 months
- Insulin pump user for at least 3 months
- Treated with rapid or ultra-rapid acting insulin analogue
Who cannot join
- Physical or psychological disease likely to interfere with normal conduct of the study
- Untreated coeliac disease or thyroid disease
- Current treatment with drugs known to interfere with glucose metabolism
- Subject/carer's severe visual impairment
- Subject/carer's severe hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study
The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.
The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CGM | CGM users | |
| SMBG | Non-CGM users |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation
Measured: 1 year
Secondary outcomes (2)
Time in Range
Time in Range 70 - 180 mg/dl
Measured: 1 year
Time Above Range
Time in Range above 180 mg/dl
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Jun 2018
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 339 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- International Society for Pediatric and Adolescent Diabetes, Kinderkrankenhaus auf der Bult, Hannover, Germany, Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland, Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy, Yale University, Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal, Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy, Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal, Diaboss, Amsterdam, Netherlands, Medical School, University of Valparaiso, San Felipe, Chile., Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey., University of Roma La Sapienza, Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558710
- Sponsor's protocol ID
- VibRate Study
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study
- ClinicalTrials.gov ID
- NCT04558710
- Acronym / sponsor ID
- VibRate Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Collaborators
- International Society for Pediatric and Adolescent Diabetes, Kinderkrankenhaus auf der Bult, Hannover, Germany, Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland, Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy, Yale University, Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal, Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy, Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal, Diaboss, Amsterdam, Netherlands, Medical School, University of Valparaiso, San Felipe, Chile., Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey., University of Roma La Sapienza, Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 22 Sep 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.
The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.
The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM | – | –CGM users |
| SMBG | – | –Non-CGM users |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and treated with insulin pump fo at least 3 months.
Key inclusion criteria (4 listed)
- Age below 7 years of age (at inclusion)
- Type 1 diabetes for at least 6 months
- Insulin pump user for at least 3 months
- Treated with rapid or ultra-rapid acting insulin analogue
Key exclusion criteria (5 listed)
- Physical or psychological disease likely to interfere with normal conduct of the study
- Untreated coeliac disease or thyroid disease
- Current treatment with drugs known to interfere with glucose metabolism
- Subject/carer's severe visual impairment
- Subject/carer's severe hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coefficient of variation
Time frame: 1 year
2 secondary outcomes
Time in Range
Time frame: 1 year
Time Above Range
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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?
An observational study of Type 1 Diabetes and Continuous Glucose Monitoring, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
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 5 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: finished, as of the sponsor's last update on 10 May 2023. 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coefficient of variation (time frame: 1 year). 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 10 May 2023.