Type 1 Diabetes MellitusNCT03182842
FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes
A study testing FreeStyle Libre FGM and SMBG - Blinded Sensor in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
Trial summary
A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM … Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia, Hyperglycemia
- What is being tested?
- FreeStyle Libre FGM and SMBG - Blinded Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Jun 2017to 1 Jul 2017
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least six month prior to study enrolment 2. Documented evidence should exist within the patient history of T1D 3. The subject is between six and 15 years of age (inclusive) at the time of enrolment 4. The subject has been treated with an insulin pump for at least 3 months 5. The subject has an A1C value between 6.3 and 10% (both inclusive) based on analysis from the local laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
- 6. The subject is willing to follow all study instructions 7. Subject is willing to perform daily self-monitoring of blood glucose (SMBG). 8. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator 9. Subject has a BMI above 5th centile and below 95th centile for age, respectively.
Who cannot join
- 1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
- 2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder) 3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study.
- 4. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
- 5. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening.
- 6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
- 7. Subject has known hypoglycemic unawareness or recurrent severe hypoglycemic events with seizure and/or coma (more than two episodes) within 6 months prior to screening.
- 8. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.
- 9. Subject has current or recent history of alcohol or drug abuse. 10. Subject has visual impairment or hearing loss, which in the investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of FreeStyle Libre Flash Glucose Monitoring System During a Children With Type 1 Diabetes Summer Camp - The Free Summer Study
A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control).
Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6).
Read more
The objectives of this clinical investigation is:
- to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia, Hyperglycemia
- Being tested
- FreeStyle Libre FGM, SMBG - Blinded Sensor
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre FGMDevice
Also called Intervention - Sensor ON
Insulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus.
SMBG - Blinded SensorDevice
Also called Control
Insulin dosing based on SMBG
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre FGM | Experimental | Insulin dosing based on FreeStyle Libre FGM glucose values Receives: Device: FreeStyle Libre FGM |
| SMBG - Blinded Sensor - Control | Active comparator | Insulin dosing based on SMBG, FreeStyle Libre FGM will be blinded. Receives: Device: SMBG - Blinded Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time within 3.9 and 10 mmol/l
between-group difference (FGM versus SMBG) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during two weeks of diabetes summer camp based on sensor glucose readings
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start17 Jun 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tadej Battelino, Prof., Principal investigator, Head, Chair of Pediatrics, Faculty of Medicine Vice Dean for Research, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182842
- Sponsor's protocol ID
- Free-Summer-01
- Status last verified
- Jul 2017
- First submitted
- 7 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Piona C, Dovc K, Mutlu GY, Grad K, Gregorc P, Battelino T, Bratina N. Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study. Pediatr Diabetes. 2018 Nov;19(7):1285-1293. doi: 10.1111/pedi.12729. Epub 2018 Aug 16.
PubMed 30022571
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of FreeStyle Libre Flash Glucose Monitoring System During a Children With Type 1 Diabetes Summer Camp - The Free Summer Study
- ClinicalTrials.gov ID
- NCT03182842
- Acronym / sponsor ID
- Free-Summer-01
- Conditions
- Type 1 Diabetes Mellitus, Hypoglycemia, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 9 Jun 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.
A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control).
Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6).
The objectives of this clinical investigation is:
- to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre FGM | Experimental | Device: FreeStyle Libre FGMInsulin dosing based on FreeStyle Libre FGM glucose values |
| SMBG - Blinded Sensor - Control | Active comparator | Device: SMBG - Blinded SensorInsulin dosing based on SMBG, FreeStyle Libre FGM will be blinded. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least six month prior to study enrolment 2. Documented evidence should exist within the patient history of T1D 3. The subject is between six and 15 years of age (inclusive) at the time of enrolment 4. The subject has been treated with an insulin pump for at least 3 months 5. The subject has an A1C value between 6.3 and 10% (both inclusive) based on analysis from the local laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
- 6. The subject is willing to follow all study instructions 7. Subject is willing to perform daily self-monitoring of blood glucose (SMBG). 8. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator 9. Subject has a BMI above 5th centile and below 95th centile for age, respectively.
Key exclusion criteria (8 listed)
- 1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
- 2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder) 3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study.
- 4. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
- 5. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening.
- 6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
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 |
|---|---|---|
| FreeStyle Libre FGMAlso: Intervention - Sensor ONInsulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus. | Device | FreeStyle Libre FGM |
| SMBG - Blinded SensorAlso: ControlInsulin dosing based on SMBG | Device | SMBG - Blinded Sensor - Control |
Primary outcome
Time within 3.9 and 10 mmol/l
Time frame: Two weeks
between-group difference (FGM versus SMBG) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during two weeks of diabetes summer camp based on sensor glucose readings
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 5 Jul 2017.
- Derived from this study: PubMed 30022571Piona C, Dovc K, Mutlu GY, Grad K, Gregorc P, Battelino T, Bratina N. Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study. Pediatr Diabetes. 2018 Nov;19(7):1285-1293. doi: 10.1111/pedi.12729. Epub 2018 Aug 16.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Tadej Battelino, Prof. principal investigator
Head, Chair of Pediatrics, Faculty of Medicine Vice Dean for Research, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre FGM and SMBG - Blinded Sensor in people with Type 1 Diabetes Mellitus and Hypoglycemia, 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 2 inclusion and 8 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 5 Jul 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?
Time within 3.9 and 10 mmol/l (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182842, which also lists 1 linked publication.
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 5 Jul 2017.