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

Status Completed

Clinical 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 - 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03182842
Study type	Interventional
Source	University of Ljubljana, Faculty of Medicine
Contact
Status	Completed
Phase	N/A
Start date	June 17, 2017
Completion date	July 1, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04476472` - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort	N/A
Completed	`NCT03635437` - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes	Phase 1/Phase 2
Completed	`NCT04909580` - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes	N/A
Active, not recruiting	`NCT00679042` - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol	Phase 3
Completed	`NCT03293082` - Preschool CGM Use and Glucose Variability in Type 1 Diabetes	N/A
Completed	`NCT04016662` - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)	Phase 4
Completed	`NCT02527265` - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients	Phase 2
Completed	`NCT03738865` - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes	Phase 3
Completed	`NCT03240432` - Wireless Innovation for Seniors With Diabetes Mellitus	N/A
Completed	`NCT03168867` - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)	N/A
Completed	`NCT03674281` - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System	N/A
Completed	`NCT03669770` - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting	`NCT03682640` - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes	Phase 2
Recruiting	`NCT04096794` - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed	`NCT02882737` - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus	N/A
Recruiting	`NCT02745808` - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Completed	`NCT02596204` - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring	N/A
Completed	`NCT02562313` - A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®	Phase 1
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A
Withdrawn	`NCT02579148` - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1