Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if blood sugar monitoring using a FreeStyle Libre device can improve overall Diabetes control in people with Type 2 Diabetes.
The main questions it aims to answer are:
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.
This is a prospective, randomised, open-labelled, non-CTIMP, pilot study. Participants meeting the inclusion criteria and who have consented to participate in the study will be randomised on a 1:1 ratio to receive either Libre 2 or Libre pro iQ. Randomisation will be carried out using an online randomisation tool to allocate a participant to a treatment group.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeStyle Libe 2 | Active Comparator | Participants in this group will wear the FreeStyle Libre 2 device |
|
| FreeStyle Libre pro iQ | Active Comparator | Participants in this arm will wear the FreeStyle Libre pro iQ device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose monitoring using FreeStyle Libre 2 | Device | Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a change in HbA1c of 5.5 mmol/mol or more | The number of participants with a change in HbA1c of 5.5 mmol/mol or more at the end of the study compared to baseline HbA1c | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Diabetes Quality of Life (DQOL) score | Change in Diabetes Quality of Life (DQOL) score from baseline to end of the study. The total scores range from 0 (lowest possible quality of life) to 100 (highest possible quality of life). Higher scores mean a better outcome | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thozhukat Sathyapalan, FRCP,FACP | University of Hull | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism | Hull | HU32RW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291106 | Background | 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. | |
| 32669277 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Glucose monitoring using FreeStyle Libre pro iQ | Device | Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ |
|
| Background |
| 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. |
| 28137708 | Background | 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. |