- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06268808
Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a post-market, multi-centre, prospective, interventional single arm study in Italy.
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pamela Reid, PhD
- Phone Number: +441993863024
- Email: pamela.reid@abbott.com
Study Locations
-
-
-
Bari, Italy
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
-
Contact:
- Francesco Giorgino
-
Catania, Italy
- Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia
-
Contact:
- Lucia Frittitta
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Catania, Italy
- Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna
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Contact:
- Salvatore Piro
-
Padova, Italy
- Azienda Ospedaliera - Università di Padova
-
Contact:
- Gian Paolo Fadini
-
Parma, Italy
- Azienda Ospedaliero-Universitaria di Parma
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Contact:
- Riccardo Bonadonna
-
Rome, Italy
- La Sapienza Università di Roma, AOU Policlinico Umberto I
-
Contact:
- Raffaella Buzzetti
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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.
- Currently receiving dialysis treatment or receives dialysis during the study.
- A female participant who is pregnant.
- A breastfeeding female participant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
FreeStyle Libre 2 Flash Glucose Monitoring System
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 3 months
|
Change in HbA1c within group from baseline
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in range (TIR)
Time Frame: 3 months
|
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)
|
3 months
|
Time above range (TAR)
Time Frame: 3 months
|
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 months
|
Time below range (TBR)
Time Frame: 3 months
|
Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL).
|
3 months
|
Frequency of hypoglycaemia events
Time Frame: 3 months
|
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9mmol/L (<70mg/dL)
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francesco Giorgino, MD, PhD, Azienda ospedaliero-universitaria consorziale policlinico di Bari
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADC-UK-PMS-23058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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