Patients Perceptions of Using the "Libre" System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial

Patients Perceptions of Using the Libre System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial

The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Every scan shows the current glucose reading and the last 8 hours of glucose. There are no alarms and the system does not require calibration.

In the present study we aim to evaluate treatment satisfaction and comfort using the Libre flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose monitoring.

The second aim of the study is to evaluate the rate of use and the impact of Libre use compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally controlled and stopped using Continuous Glucose Monitoring. The study is an investigator initiated study, single-center, randomized, parallel study of 12 weeks with an optional cross-over 12 weeks extension period .

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Libre Flash CGMS; Device: Self-Measurement Blood Glucose

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject has documented Type 1 Diabetes , as defined by the American Diabetes Association and World Health Organization for at least 1 year prior to study enrollment
• The subject used continuous glucose monitoring until 3 months or more before the study start
• Age 12-17 years
• The subject has an HbA1c value > 7.5% at time of screening visit
• The subject is willing to follow study instructions
• Subject is available for entire study duration

Exclusion Criteria:

• Concomitant diseases that influence metabolic control or other medical condition, which in the Investigator's opinion, may compromise patient safety
• Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study
• Any significant diseases or conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety
• Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to 7 days
• Subject has known allergy to medical grade adhesives
• 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
• Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration or is not using adequate contraceptive methods
• Subject diagnosed with current eating disorder such as anorexia or bulimia
• Subject has a history of one or more episodes of Diabetes Keto-Acidosis requiring hospitalization within a month prior to screening
• Subject has unstable or rapidly progressive renal disease or is receiving dialysis
• Subject has active proliferating retinopathy
• Subject has current or recent history of alcohol or drug abuse
• Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely
• Any disease or condition that may influence the HbA1C testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Libre Flash CGMS (Continuous Monitoring System); Patients will use the Libre Flash Continuous Glucose Monitoring System for 12 weeks for their glucose Management	Device: Libre Flash CGMS
Active Comparator: SMBG; Patients will use Self-Monitoring of Blood Glucose for 12 weeks for their glucose management	Device: Self-Measurement Blood Glucose; Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Treatment satisfaction questionnaire		At the final visit- week 12
Libre-user evaluation questionnaire	20-item questionnaire that asses treatment satisfaction with the Libre including ease of use, comfort, pain, design and system operation. The questionnaire will be scored to a final score integrating all items to a total score	At the final visit-week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Glycemic control measured by HbA1c	At the final visit-week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of blood glucose measurements at each arm		At the final visit-week 12
Number of flash glucose measurements at the intervention arm		At the final visit-week 12
Percentage of glucose sensor readings within the range of 70 to 180 mg/dl		At the final visit-week 12
Percentage of glucose sensor readings below 60 mg/dl		At the final visit-week 12
Percentage of glucose sensor readings above 240 mg/dl		At the final visit-week 12
Average of glucose sensor readings	Average of glucose sensor readings (per 24 hours)	Week 12
Standard Deviation of glucose sensor readings	Standard Deviation of glucose sensor readings (per 24 hours) )	Week 12
HbA1c change from baseline to the end of the first intervention period		At the final visit-week 12
HbA1c change from baseline to the end of the second intervention period		At the final visit-week 12
Average fasting blood glucose level		At the final visit-week 12

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Abbott

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: May 15, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring System
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: RMC023516Ctil