CGM Use in Adults With Type 2 Diabetes on Basal Insulin

• Sponsor: Abbott Diabetes Care (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05944432
• Collaborator: (none)
• Enrollment: 430
• Locations: 17
• Arms: 2
• Anticipated Duration (Months): 21.7
• Patients Per Site: 25.3
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.; Device: Self monitoring of blood glucose	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 10, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FreeStyle Libre system FreeStyle Libre 3 continuous glucose monitoring system	Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.; Subjects will be randomised to use the FreeStyle Libre 3 system
Other: Standard of care (control) Self monitoring of blood glucose	Device: Self monitoring of blood glucose; Subjects will be randomised to continue with their current glucose monitoring system

Outcome Measures

Primary Outcome Measures

1. HbA1c [16 weeks]

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

2. HbA1c [32 weeks]

   Difference between treatment groups in mean change from baseline in HbA1c

Secondary Outcome Measures

1. Time in range (TIR) [32 weeks]

   Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).

2. Time above range (TAR) [32 weeks]

   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).

3. Time below range(TBR) [32 weeks]

   Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL).

4. Frequency of hypoglycaemia events [32 weeks]

   CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth Hospital	Birmingham		United Kingdom
2	Brighton General Hospital	Brighton		United Kingdom
3	Cambridge University Hospital (Addenbrookes)	Cambridge		United Kingdom
4	Darlington Memorial Hospital	Darlington		United Kingdom
5	Royal Derby Hospital	Derby		United Kingdom	DE22 3NE
6	Hull Royal Infirmary	Hull		United Kingdom
7	Ipswich Hospital	Ipswich		United Kingdom
8	St James University Hospital	Leeds		United Kingdom
9	Leicester General Hospital	Leicester		United Kingdom
10	King's College Hospital	London		United Kingdom
11	Manchester Royal Infirmary	Manchester		United Kingdom	M13 9WU
12	Norfolk and Norwich University Hospital	Norwich		United Kingdom
13	Churchill Hospital	Oxford		United Kingdom
14	The Adam Practice	Poole		United Kingdom
15	Queen Alexandra Hospital	Portsmouth		United Kingdom
16	Northern General Hospital	Sheffield		United Kingdom
17	Singleton Hospital	Swansea		United Kingdom

Sponsors and Collaborators

• Abbott Diabetes Care

Investigators

• Study Director: Pamela Reid, Abbott Diabetes Care Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Diabetes Care
• ClinicalTrials.gov Identifier: NCT05944432
• Other Study ID Numbers: ADC-UK-PMS-22057
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 13, 2023