Type2diabetes
Conditions
Brief summary
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: * 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
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.
Interventions
DEVICEGlucose monitoring using FreeStyle Libre 2
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2
DEVICEGlucose monitoring using FreeStyle Libre pro iQ
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ
Sponsors
University of Hull
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years * On one or more non-insulin glucose lowering agent(s) * HbA1c ≥ 69 mmol/mol * Able to provide written informed consent
Exclusion criteria
* Participants with a life expectancy of less than 1 year * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a change in HbA1c of 5.5 mmol/mol or more | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Diabetes Quality of Life (DQOL) score | 12 weeks | 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 |
Countries
United Kingdom
Outcome results
None listed