Type 2 Diabetes Treated With InsulinNCT06268821
Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
A study testing FreeStyle Libre 2 Flash Glucose Monitoring System in people with Type 2 Diabetes Treated With Insulin, run by Abbott Diabetes Care at 2 sites in Finland.
Trial summary
The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin
- What is being tested?
- FreeStyle Libre 2 Flash Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFinland
- Study dates
- 2 Apr 2024to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 to ≤ 75 years.
- Type 2 diabetes diagnosis ≥1 year prior to enrolment.
- Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
- Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
- Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.
Who cannot join
- 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.
- Currently receiving dialysis treatment or receives dialysis during the study.
- A female participant who is pregnant.
- A breastfeeding female participant.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Pihlajalinna Jämsä, Välikatu 1,
Jämsä, 42100
Pihlajalinna Koskiklinikka, Hatanpäänvaltatie 1,
Tampere, 33100
About this study
Official title: The Effect on HbA1c of the Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
Read the detailed description
This is a post-market, multi-centre, prospective, interventional single arm study in Finland.
Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.
HbA1c will be tested at the start and end of the study for primary endpoint analysis.
- Conditions
- Type 2 Diabetes Treated With Insulin
- Being tested
- FreeStyle Libre 2 Flash Glucose Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 2 Flash Glucose Monitoring SystemDevice
Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | FreeStyle Libre 2 Flash Glucose Monitoring System Receives: Device: FreeStyle Libre 2 Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Change in HbA1c within group from baseline
Measured: 3 months
Secondary outcomes (4)
Time in range (TIR)
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)
Measured: 3 months
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).
Measured: 3 months
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).
Measured: 3 months
Frequency of hypoglycaemia events
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9mmol/L (<70mg/dL)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Apr 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henri Honka, MD, PhD, Principal investigator, Pihlajalinna, Jämsä
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268821
- Sponsor's protocol ID
- ADC-UK-PMS-23059
- Status last verified
- Sep 2024
- First submitted
- 13 Feb 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on HbA1c of the Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland
- ClinicalTrials.gov ID
- NCT06268821
- Acronym / sponsor ID
- ADC-UK-PMS-23059
- Conditions
- Type 2 Diabetes Treated With Insulin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
Detailed description
This is a post-market, multi-centre, prospective, interventional single arm study in Finland.
Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.
HbA1c will be tested at the start and end of the study for primary endpoint analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: FreeStyle Libre 2 Flash Glucose Monitoring SystemFreeStyle Libre 2 Flash Glucose Monitoring System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 to ≤ 75 years.
- Type 2 diabetes diagnosis ≥1 year prior to enrolment.
- Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
- Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
- Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.
Key exclusion criteria (5 listed)
- 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.
- Currently receiving dialysis treatment or receives dialysis during the study.
- A female participant who is pregnant.
- A breastfeeding female participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre 2 Flash Glucose Monitoring SystemGlucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise) | Device | Intervention |
Primary outcome
HbA1c
Time frame: 3 months
Change in HbA1c within group from baseline
4 secondary outcomes
Time in range (TIR)
Time frame: 3 months
Time above range (TAR)
Time frame: 3 months
Time below range (TBR)
Time frame: 3 months
Frequency of hypoglycaemia events
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henri Honka, MD, PhD principal investigator
Pihlajalinna, Jämsä
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre 2 Flash Glucose Monitoring System in people with Type 2 Diabetes Treated With Insulin, run by Abbott Diabetes Care at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.