Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
ConditionDiabetes Mellitus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Diabetes Care
About this trial
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be at least 18 years of age.
Subject must be able to read and understand English.
Subject must have a type 2 diabetes diagnosis.
In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
Disqualifiers
Subject is a member of the Study Staff.
Subject has a diagnosis of type 1 or gestational diabetes.
Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
Trial population
Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
DeviceAll subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Randomization to FSL 3 or Standard of Care1 intervention
Trial outcomes
Primary outcomes
1
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug
The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.
Time frame
210 daysSponsors and contacts
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Source ClinicalTrials.gov