NCT03182842

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

Evaluation of FreeStyle Libre Flash Glucose Monitoring System During a Children With Type 1 Diabetes Summer Camp - The Free Summer Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Ljubljana, Faculty of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	SMBG - Blinded Sensor	Insulin dosing based on SMBG

Timeline

• Start date: 2017-06-17
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-06-09
• Last updated: 2017-07-05

Locations

1 site across 1 country: Slovenia

Regulatory

• FDA-regulated device study