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FreeStyle Libre Monitoring in T2DM

Primary Purpose

Type2diabetes

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Glucose monitoring using FreeStyle Libre 2

Glucose monitoring using FreeStyle Libre pro iQ

About this trial

This is an interventional diagnostic trial for Type2diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolismRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FreeStyle Libe 2

FreeStyle Libre pro iQ

Arm Description

Participants in this group will wear the FreeStyle Libre 2 device

Participants in this arm will wear the FreeStyle Libre pro iQ device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05597293

First Posted

October 24, 2022

Last Updated

October 10, 2023

Sponsor

University of Hull

1. Study Identification

Unique Protocol Identification Number

NCT05597293

Brief Title

FreeStyle Libre Monitoring in T2DM

Official Title

Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People With Type 2 Diabetes Mellitus (T2DM)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 27, 2023 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Hull

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2diabetes

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FreeStyle Libe 2

Arm Type

Active Comparator

Arm Description

Participants in this group will wear the FreeStyle Libre 2 device

Arm Title

FreeStyle Libre pro iQ

Arm Type

Active Comparator

Arm Description

Participants in this arm will wear the FreeStyle Libre pro iQ device

Intervention Type

Device

Intervention Name(s)

Glucose monitoring using FreeStyle Libre 2

Intervention Description

Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre 2

Intervention Type

Device

Intervention Name(s)

Glucose monitoring using FreeStyle Libre pro iQ

Intervention Description

Glucose monitoring in patients with type 2 diabetes using FreeStyle Libre pro iQ

Primary Outcome Measure Information:

Title

Number of participants with a change in HbA1c of 5.5 mmol/mol or more

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in the Diabetes Quality of Life (DQOL) score

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chair in Academic Diabetes, Endocrinology and Metabolism

Phone

+441482675387

thozhukat.sathyapalan@hyms.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thozhukat Sathyapalan, FRCP,FACP

Organizational Affiliation

University of Hull

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hull University Teaching Hospitals NHS Trust, Academic diabetes, Endocrinology and metabolism

City

Hull

ZIP/Postal Code

HU32RW

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thozhukat Sathyapalan, MD FRCP

Phone

+441482675312

thozhukat.sathyaplan@hyms.ac.uk

First Name & Middle Initial & Last Name & Degree

Najeeb Shah, MBBS, MRCP

Phone

+441482675387

hyns17@hyms.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30291106

Citation

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.

Results Reference

background

PubMed Identifier

32669277

Citation

Deshmukh 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.

Results Reference

background

PubMed Identifier

28137708

Citation

Edge 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.

Results Reference

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FreeStyle Libre Monitoring in T2DM

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