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Clinical Trial NCT05944432 for Diabetes Mellitus, Type 2 is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Abbott Diabetes CareCGM Use in Adults With Type 2 Diabetes on Basal Insulin 470 Open-Label
Clinical Trial NCT05944432 is an interventional study for Diabetes Mellitus, Type 2 that is active, not recruiting. It started on July 14, 2023 with plans to enroll 470 participants. Led by Abbott Diabetes Care, it is expected to complete by November 30, 2027. The latest data from ClinicalTrials.gov was last updated on February 12, 2026.
Brief Summary
A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.
Detailed Description
The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.
Official Title
Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
Conditions
Diabetes Mellitus, Type 2Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- ADC-UK-PMS-22057
NCT ID Number
Start Date (Actual)
2023-07-14
Last Update Posted
2026-02-12
Completion Date (Estimated)
2027-11-30
Enrollment (Estimated)
470
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorFreeStyle Libre system FreeStyle Libre 3 continuous glucose monitoring system | FreeStyle Libre 3 Continuous Glucose Monitoring System. Subjects will be randomised to use the FreeStyle Libre 3 system |
OtherStandard of care (control) Self monitoring of blood glucose | Self monitoring of blood glucose Subjects will be randomised to continue with their current glucose monitoring system |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HbA1c | Difference between treatment groups in mean change from baseline in HbA1c. | 16 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
HbA1c | Difference between treatment groups in mean change from baseline in HbA1c | 32 weeks |
Time in range (TIR) | Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL). | 32 weeks |
Time above range (TAR) | Time spent above glucose target range (TAR) \>10.0 mmol/L, 13.9 mmol/L and 16.7 mmol/L (\>180 mg/dL, \>250 mg/dL and \>300 mg/dL). | 32 weeks |
Time below range(TBR) | Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL). | 32 weeks |
Frequency of hypoglycaemia events | CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL). | 32 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Aged 18 years or over.
- Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
- Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.
- Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).
- Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
- Currently participating in another study that could affect glucose measurements or glucose management.
- A female participant who is pregnant.
- A breastfeeding female participant.
- Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.
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25 Study Locations in 1 Countries
Tameside General Hospital, Ashton-under-Lyne, United Kingdom
Royal United Hospital, Bath, United Kingdom
Queen Elizabeth Hospital, Birmingham, United Kingdom
Cambridge University Hospital (Addenbrookes), Cambridge, United Kingdom
Darlington Memorial Hospital, Darlington, United Kingdom
Royal Derby Hospital, Derby, DE22 3NE, United Kingdom
Ninewells Hospital, Dundee, United Kingdom
Princess Alexandra Hospital, Harlow, United Kingdom
Northwick Park Hospital, Harrow, United Kingdom
Hull Royal Infirmary, Hull, United Kingdom
Ipswich Hospital, Ipswich, United Kingdom
St James University Hospital, Leeds, United Kingdom
Leicester General Hospital, Leicester, United Kingdom
King's College Hospital, London, United Kingdom
St Mary's Hospital, London, United Kingdom
Manchester Royal Infirmary, Manchester, M13 9WU, United Kingdom
Norfolk and Norwich University Hospital, Norwich, United Kingdom
Churchill Hospital, Oxford, United Kingdom
Derriford Hospital, Plymouth, United Kingdom
The Adam Practice, Poole, United Kingdom
Queen Alexandra Hospital, Portsmouth, United Kingdom
Northern General Hospital, Sheffield, United Kingdom
Moorgreen Hospital, Southampton, United Kingdom
Singleton Hospital, Swansea, United Kingdom
Wishaw Hospital, Wishaw, United Kingdom