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CGM Use in Adults With Type 2 Diabetes on Basal Insulin
CGM Use in Adults With Type 2 Diabetes on Basal Insulin

NCT05944432

Active Not RecruitingNA

Sponsor: Abbott Diabetes Care

Conditions: Diabetes Mellitus, Type 2

Interventions: FreeStyle Libre 3 Continuous Glucose Monitoring System., Self monitoring of blood glucose

Countries: United Kingdom

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. Following completion of the 8-month period for all participants, an optional non-interventional follow-up period will assess glycaemic control and treatment patterns over 24 months.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
Locations (25)
  • Ashton-under-Lyne, United Kingdom
  • Bath, United Kingdom
  • Birmingham, United Kingdom
  • Cambridge, United Kingdom
  • Darlington, United Kingdom
  • Derby, United Kingdom
  • Dundee, United Kingdom
  • Harlow, United Kingdom
  • Harrow, United Kingdom
  • Hull, United Kingdom
  • Ipswich, United Kingdom
  • Leeds, United Kingdom
  • Leicester, United Kingdom
  • London, United Kingdom
  • London, United Kingdom
  • Manchester, United Kingdom
  • Norwich, United Kingdom
  • Oxford, United Kingdom
  • Plymouth, United Kingdom
  • Poole, United Kingdom
  • Portsmouth, United Kingdom
  • Sheffield, United Kingdom
  • Southampton, United Kingdom
  • Swansea, United Kingdom
  • Wishaw, United Kingdom