FreeStyle Libre FGM During Summer Camp for Children With Type 1 Diabetes

NCT ID: NCT03182842

Last Updated: 2017-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-17
• Study Completion Date: 2017-07-01

Brief 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 - 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:

1. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

FreeStyle Libre FGM

Insulin dosing based on FreeStyle Libre FGM glucose values

Group Type: EXPERIMENTAL

FreeStyle Libre FGM

Intervention Type: DEVICE

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 Sensor - Control

Insulin dosing based on SMBG, FreeStyle Libre FGM will be blinded.

Group Type: ACTIVE_COMPARATOR

SMBG - Blinded Sensor

Intervention Type: DEVICE

Insulin dosing based on SMBG

Interventions

FreeStyle Libre FGM

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.

Intervention Type: DEVICE

SMBG - Blinded Sensor

Insulin dosing based on SMBG

Intervention Type: DEVICE

Other Intervention Names

Intervention - Sensor ON; Control

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tadej Battelino, Prof.

Role: PRINCIPAL_INVESTIGATOR

Head, Chair of Pediatrics, Faculty of Medicine Vice Dean for Research, Faculty of Medicine

Locations

Medical Faculty - University of Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

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.

Reference Type: DERIVED

PMID: 30022571 (View on PubMed)

Other Identifiers

Free-Summer-01

Identifier Type: -

Identifier Source: org_study_id