Type 1 Diabetes MellitusNCT03293082
Preschool CGM Use and Glucose Variability in Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
Trial summary
The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CGM ON and CGM OFF
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2017to 30 Sep 2017
- How long will I take part?
- 3 Years
- 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 Up to 7 years
- All sexes
- Child
Study population: Population of preschool children with type 1 diabetes aged up to 7 years that were prescribed sensor use in the observational period.
Who may be able to join
- Subject with Type 1 diabetes (\> 6 months since diagnosis)
- Insulin infusion pump CSII therapy for at least 3 months
- Age ≤ 7 years
- HbA1c at inclusion ≥ 6.5 and < 10
- BMI SDS - below the 95th percentile for age
Who cannot join
- Concomitant diseases that influence metabolic control
- Participation in any other interventional study
- Known or suspected allergy to trial products
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
UMC - University Children's Hospital Ljubljana
Ljubljana, 1000
About this study
Official title: The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.
Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- CGM ON, CGM OFF
- 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.
CGM ONDevice
The period of time when continuous glucose monitoring was used, in edition to SMBG
CGM OFFDevice
The period of time when continuous glucose monitoring was not used, only SMBG
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability
Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
Measured: Three years
Secondary outcomes (3)
Mean intersticial glucose
Mean glucose as measured with CGM
Measured: Three years
Mean blood glucose
Mean glucose as measured with SMBG
Measured: Three years
HbA1c
glycosilated hemoglobin
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start30 Sep 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293082
- Sponsor's protocol ID
- CGM-GV-Preschool- SI-01
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03293082
- Acronym / sponsor ID
- CGM-GV-Preschool- SI-01
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Sep 2017 (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 objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.
Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Population of preschool children with type 1 diabetes aged up to 7 years that were prescribed sensor use in the observational period.
Key inclusion criteria (5 listed)
- Subject with Type 1 diabetes (\> 6 months since diagnosis)
- Insulin infusion pump CSII therapy for at least 3 months
- Age ≤ 7 years
- HbA1c at inclusion ≥ 6.5 and < 10
- BMI SDS - below the 95th percentile for age
Key exclusion criteria (3 listed)
- Concomitant diseases that influence metabolic control
- Participation in any other interventional study
- Known or suspected allergy to trial products
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 |
|---|---|---|
| CGM ONThe period of time when continuous glucose monitoring was used, in edition to SMBG | Device | – |
| CGM OFFThe period of time when continuous glucose monitoring was not used, only SMBG | Device | – |
Primary outcome
Glucose variability
Time frame: Three years
Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
3 secondary outcomes
Mean intersticial glucose
Time frame: Three years
Mean blood glucose
Time frame: Three years
HbA1c
Time frame: Three years
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 3 Oct 2017.
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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 Mellitus, 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 5 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: finished, as of the sponsor's last update on 3 Oct 2017. 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?
Glucose variability (time frame: Three years). 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 3 Oct 2017.