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CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FreeStyle Libre 3 Continuous Glucose Monitoring System.
Self monitoring of blood glucose
Sponsored by
Abbott Diabetes Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 GLP1. 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.

Sites / Locations

  • Queen Elizabeth Hospital
  • Cambridge University Hospital (Addenbrookes)
  • Darlington Memorial HospitalRecruiting
  • Royal Derby HospitalRecruiting
  • Hull Royal InfirmaryRecruiting
  • Ipswich HospitalRecruiting
  • St James University Hospital
  • Leicester General HospitalRecruiting
  • King's College Hospital
  • Manchester Royal Infirmary
  • Norfolk and Norwich University HospitalRecruiting
  • Churchill Hospital
  • The Adam PracticeRecruiting
  • Queen Alexandra Hospital
  • Northern General HospitalRecruiting
  • Singleton HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

FreeStyle Libre system

Standard of care (control)

Arm Description

FreeStyle Libre 3 continuous glucose monitoring system

Self monitoring of blood glucose

Outcomes

Primary Outcome Measures

HbA1c
Difference between treatment groups in mean change from baseline in HbA1c.
HbA1c
Difference between treatment groups in mean change from baseline in HbA1c

Secondary Outcome Measures

Time in range (TIR)
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
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).
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).
Frequency of hypoglycaemia events
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL).

Full Information

First Posted
July 6, 2023
Last Updated
October 4, 2023
Sponsor
Abbott Diabetes Care
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1. Study Identification

Unique Protocol Identification Number
NCT05944432
Brief Title
CGM Use in Adults With Type 2 Diabetes on Basal Insulin
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Diabetes Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 or 32 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FreeStyle Libre system
Arm Type
Active Comparator
Arm Description
FreeStyle Libre 3 continuous glucose monitoring system
Arm Title
Standard of care (control)
Arm Type
Other
Arm Description
Self monitoring of blood glucose
Intervention Type
Device
Intervention Name(s)
FreeStyle Libre 3 Continuous Glucose Monitoring System.
Intervention Description
Subjects will be randomised to use the FreeStyle Libre 3 system
Intervention Type
Device
Intervention Name(s)
Self monitoring of blood glucose
Intervention Description
Subjects will be randomised to continue with their current glucose monitoring system
Primary Outcome Measure Information:
Title
HbA1c
Description
Difference between treatment groups in mean change from baseline in HbA1c.
Time Frame
16 weeks
Title
HbA1c
Description
Difference between treatment groups in mean change from baseline in HbA1c
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Time in range (TIR)
Description
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
Time Frame
32 weeks
Title
Time above range (TAR)
Description
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).
Time Frame
32 weeks
Title
Time below range(TBR)
Description
Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL).
Time Frame
32 weeks
Title
Frequency of hypoglycaemia events
Description
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL).
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 GLP1. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Reid, PhD
Phone
01993863024
Email
pamela.reid@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Reid
Organizational Affiliation
Abbott Diabetes Care Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parth Narandran
Facility Name
Cambridge University Hospital (Addenbrookes)
City
Cambridge
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Evans
Facility Name
Darlington Memorial Hospital
City
Darlington
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shafie Kamaruddin
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma D Wilmot (Chief Investigator)
Email
emma.wilmot@nhs.net
Facility Name
Hull Royal Infirmary
City
Hull
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thozhukat Sathyapalan
Facility Name
Ipswich Hospital
City
Ipswich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerry Rayman
Facility Name
St James University Hospital
City
Leeds
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramzi Ajjan
Facility Name
Leicester General Hospital
City
Leicester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pratik Choudhary
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yee Cheah
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lalantha Leelarathna (Chief Investigator)
Email
Lalantha.Leelarathna@cmft.nhs.uk
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sankalpa Neupane
Facility Name
Churchill Hospital
City
Oxford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alistair Lumb
Facility Name
The Adam Practice
City
Poole
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Moore
Facility Name
Queen Alexandra Hospital
City
Portsmouth
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iain Cranston
Facility Name
Northern General Hospital
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Iqbal
Facility Name
Singleton Hospital
City
Swansea
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thinzar MIn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

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