Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-02-27
2024-05-02
Brief Summary
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The main questions it aims to answer are:
* What is the effect of monitoring using the FreeStyle Libre device for a period of 12 weeks on the blood sugar control of people with Type 2 Diabetes?
* Can monitoring using the FreeStyle Libre device improve the quality of life of people with Type 2 diabetes?
Participants will be asked to wear one of two brands of FreeStyle Libre devices. In one group, participants will have 3 visits, while those in the second group, they will have 4 visits.
Researchers will compare the improvement in the sugar control for the individuals but also compare between the 2 groups.
Detailed Description
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The study will consist of three visits (Libre 2 arm) and four visits (Libre pro iQ arm). The study will be completed over 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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FreeStyle Libe 2
Participants in this group will wear the FreeStyle Libre 2 device
Glucose monitoring using FreeStyle Libre 2
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2
FreeStyle Libre pro iQ
Participants in this arm will wear the FreeStyle Libre pro iQ device
Glucose monitoring using FreeStyle Libre pro iQ
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ
Interventions
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Glucose monitoring using FreeStyle Libre 2
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2
Glucose monitoring using FreeStyle Libre pro iQ
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ
Eligibility Criteria
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Inclusion Criteria
* On one or more non-insulin glucose lowering agent(s)
* HbA1c ≥ 69 mmol/mol
* Able to provide written informed consent
Exclusion Criteria
* Participants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoring
* Participants with chronic kidney disease (CKD) with eGFR \< 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failure
* Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
* Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
* Participants on active dialysis or planned for dialysis treatment during the study
* Currently participating in another device or drug study that could affect glucose measurements or management
* Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
* Participants who are already using continuous glucose monitoring (CGM)
* Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
* Participants with an allergy to medical grade adhesive
* A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
18 Years
75 Years
ALL
No
Sponsors
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University of Hull
OTHER
Responsible Party
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Thozhukat Sathyapalan
Professor
Principal Investigators
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Thozhukat Sathyapalan, FRCP,FACP
Role: PRINCIPAL_INVESTIGATOR
University of Hull
Locations
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Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Hull, , United Kingdom
Countries
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References
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Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.
Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
Edge J, Acerini C, Campbell F, Hamilton-Shield J, Moudiotis C, Rahman S, Randell T, Smith A, Trevelyan N. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch Dis Child. 2017 Jun;102(6):543-549. doi: 10.1136/archdischild-2016-311530. Epub 2017 Jan 30.
Other Identifiers
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301630
Identifier Type: -
Identifier Source: org_study_id