NCT05597293Completed
FreeStyle Libre Monitoring in T2DM
Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov · Last updated 24 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 24 Oct 2022
- Start date
- 27 Feb 2023
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- University of Hull
- Diseases
- Type 2 diabetes
- NCT number
- NCT05597293
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 27 Feb 2023 to the primary completion date, 11 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
Other illness
- Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
- Participants with an allergy to medical grade adhesive
Lab values
- 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
- Currently participating in another device or drug study that could affect glucose measurements or management
- Participants who are already using continuous glucose monitoring (CGM)
Other
- Participants with a life expectancy of less than 1 year
- Participants on active dialysis or planned for dialysis treatment during the study
- Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
- Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
- A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.