Type2diabetesNCT05597293
FreeStyle Libre Monitoring in T2DM
A study testing Glucose monitoring using FreeStyle Libre 2 and Glucose monitoring using FreeStyle Libre pro iQ in people with Type2diabetes, run by University of Hull at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Glucose monitoring using FreeStyle Libre 2 and Glucose monitoring using FreeStyle Libre pro iQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism
Hull, HU32RW
About this study
Official title: Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
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:
Read more
- 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.
Read the 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.
- Conditions
- Type2diabetes
- Being tested
- Glucose monitoring using FreeStyle Libre 2, Glucose monitoring using FreeStyle Libre pro iQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose monitoring using FreeStyle Libre 2Device
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2
Glucose monitoring using FreeStyle Libre pro iQDevice
Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libe 2 | Active comparator | Participants in this group will wear the FreeStyle Libre 2 device Receives: Device: Glucose monitoring using FreeStyle Libre 2 |
| FreeStyle Libre pro iQ | Active comparator | Participants in this arm will wear the FreeStyle Libre pro iQ device Receives: Device: Glucose monitoring using FreeStyle Libre pro iQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start27 Feb 2023
- Primary completion11 Mar 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thozhukat Sathyapalan, University of Hull
- Investigators
- Thozhukat Sathyapalan, FRCP,FACP, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597293
- Sponsor's protocol ID
- 301630
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30291106Deshmukh 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.
PubMed 32669277Edge 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.
PubMed 28137708
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT05597293
- Acronym / sponsor ID
- 301630
- Conditions
- Type2diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libe 2 | Active comparator | Device: Glucose monitoring using FreeStyle Libre 2Participants in this group will wear the FreeStyle Libre 2 device |
| FreeStyle Libre pro iQ | Active comparator | Device: Glucose monitoring using FreeStyle Libre pro iQParticipants in this arm will wear the FreeStyle Libre pro iQ device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose monitoring using FreeStyle Libre 2Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2 | Device | FreeStyle Libe 2 |
| Glucose monitoring using FreeStyle Libre pro iQGlucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ | Device | FreeStyle Libre pro iQ |
Primary outcome
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
1 secondary outcome
Change in the Diabetes Quality of Life (DQOL) score
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 30291106Davies 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.
- Background: PubMed 32669277Deshmukh 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.
- Background: PubMed 28137708Edge 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thozhukat Sathyapalan, FRCP,FACP principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose monitoring using FreeStyle Libre 2 and Glucose monitoring using FreeStyle Libre pro iQ in people with Type2diabetes, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a change in HbA1c of 5.5 mmol/mol or more (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597293, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.