Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type2diabetes
- Sponsor
- University of Hull
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of participants with a change in HbA1c of 5.5 mmol/mol or more
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Thozhukat Sathyapalan
Professor
University of Hull
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with a change in HbA1c of 5.5 mmol/mol or more
Time Frame: 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 Outcomes
- Change in the Diabetes Quality of Life (DQOL) score(12 weeks)