Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1

New trial tests continuous glucose monitor for Type 2 diabetes.

NCT: NCT05944432 · Status: ACTIVE NOT RECRUITING · Phase: N/A · Sponsor: Abbott Diabetes Care · Started: 2023-07-14 · Est. Completion: 2027-11-30

Plain English Summary

CGM Use in Adults With Type 2 Diabetes on Basal Insulin is a Not Applicable clinical trial sponsored by Abbott Diabetes Care studying Diabetes Mellitus, Type 2. This trial tests if a continuous glucose monitor (FreeStyle Libre 3) helps adults with Type 2 diabetes better control their blood sugar compared to standard finger-prick tests. It is for adults with Type 2 diabetes who are already on basal insulin and certain other diabetes medications (SGLT2 inhibitor and/or GLP-1) and whose blood sugar is not well-controlled. Participants will be randomly assigned to either use the FreeStyle Libre 3 system or continue with their current blood glucose monitoring method. The alternative to using the FreeStyle Libre 3 is standard self-monitoring of blood glucose using finger-prick tests. The trial aims to enroll 470 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 or older with a Type 2 diabetes diagnosis for at least one year. Individuals currently treated with basal insulin and either an SGLT2 inhibitor or GLP-1 medication (or both). People whose HbA1c (a measure of average blood sugar over 2-3 months) is between 7.5% and 11.0%. Cannot join if currently taking other types of insulin (prandial or pre-mixed), pregnant, breastfeeding, or had/planning bariatric surgery recently. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well HbA1c levels are controlled after 16 weeks, indicating the effectiveness of the continuous glucose monitor in managing long-term blood sugar. The specific primary outcome measures are: HbA1c (16 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve blood sugar control in adults with Type 2 diabetes who are on basal insulin and other specific medications, addressing a gap in optimizing treatment for this population. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.

Investor Insight

This trial, sponsored by Abbott Diabetes Care, investigates a widely used continuous glucose monitoring system, potentially impacting the market for diabetes management devices and offering a competit

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your current diabetes management plan. Participation involves being randomly assigned to use either the FreeStyle Libre 3 or your usual blood sugar testing method for 8 months. You will have regular check-ups and your blood sugar levels will be monitored. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05944432?

NCT05944432 is a Not Applicable INTERVENTIONAL study titled "CGM Use in Adults With Type 2 Diabetes on Basal Insulin." It is currently active, not recruiting and is sponsored by Abbott Diabetes Care. The trial targets enrollment of 470 participants.

What conditions does NCT05944432 study?

This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.

What treatments are being tested in NCT05944432?

The interventions being studied include: FreeStyle Libre 3 Continuous Glucose Monitoring System. (DEVICE), Self monitoring of blood glucose (DEVICE). Subjects will be randomised to use the FreeStyle Libre 3 system

What does Not Applicable mean for NCT05944432?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT05944432?

This trial is currently "Active, Not Recruiting." It started on 2023-07-14. The estimated completion date is 2027-11-30.

Who is sponsoring NCT05944432?

NCT05944432 is sponsored by Abbott Diabetes Care. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05944432?

The trial aims to enroll 470 participants. The trial status is active, not recruiting.

How is NCT05944432 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05944432?

The primary outcome measures are: HbA1c (16 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05944432 being conducted?

This trial is being conducted at 20 sites, including Ashton-under-Lyne; Bath; Birmingham; Cambridge and 16 more sites (United Kingdom).

Where can I find official information about NCT05944432?

The official record for NCT05944432 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05944432. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05944432 testing in simple terms?

This trial tests if a continuous glucose monitor (FreeStyle Libre 3) helps adults with Type 2 diabetes better control their blood sugar compared to standard finger-prick tests. It is for adults with Type 2 diabetes who are already on basal insulin and certain other diabetes medications (SGLT2 inhibitor and/or GLP-1) and whose blood sugar is not well-controlled.

Why is this trial significant?

This trial aims to improve blood sugar control in adults with Type 2 diabetes who are on basal insulin and other specific medications, addressing a gap in optimizing treatment for this population.

What are the potential risks of participating in NCT05944432?

Potential side effects of the FreeStyle Libre 3 include skin irritation where the sensor is worn. As with any diabetes management, there's a risk of low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), which the monitoring aims to help prevent. The study is open-label, meaning both participants and researchers know which treatment is being received, which could introduce bias. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05944432?

Ask your doctor if this trial is a good fit for your current diabetes management plan. Participation involves being randomly assigned to use either the FreeStyle Libre 3 or your usual blood sugar testing method for 8 months. You will have regular check-ups and your blood sugar levels will be monitored. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05944432 signal from an investment perspective?

This trial, sponsored by Abbott Diabetes Care, investigates a widely used continuous glucose monitoring system, potentially impacting the market for diabetes management devices and offering a competit This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to either use the FreeStyle Libre 3 system or continue with their current blood glucose monitoring method. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.