Clinical trial NCT04060732: Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.
Official title: Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Flash Glucose Monitoring
Glucose Monitoring
Diabetes Mellitus Type 1
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
Collaborators: name: Regione Emilia-Romagna
First posted: 2019-08-19
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Diabetes Mellitus type 1 for at least 12 months and in multi-injection insulin therapy.

Brief summary: Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease.

Self-monitoring of blood glucose (SMBG) in type 1 diabetes (T1D) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. It is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue.

Continuous glucose monitoring (CGM) is an alternative to SMBG, but the use of conventional CGM has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. The recently introduced CGM FreeStyle Libre™ (Abbott Diabetes Care, Witney, UK) flash glucose monitoring (FGM), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor.

The FGM system does not require calibration, has a long sensor lifetime of 14 days and it's relatively affordable, explaining the widespread use of the device.

The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.

Detailed description: Patients will be identified and enrolled in the Diabetes Departments of different hospitals/clinics in the Emilia Romagna region, Italy. Patients will be divided in two groups A (naive patients,) and B (patients already using the device at enrollment) and followed for 12 months.

Study design is observational prospective and includes 3-months follow up visits until the 12-month final evaluation.

At each visit, patient clinical data, adherence and side effects will be recorded and data download from the device will be performed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Diabetes Mellitus type 1 for at least 12 months
* Multi-injection insulin therapy
* C-peptide \<0.2 nmol/L
* At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement).

Exclusion Criteria:

* Diabetes Mellitus type 2
* Other types of diabetes
* Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.

Primary outcomes:
measure: Severe hypoglycemia rate
timeFrame: 12 months
measure: Severe hypoglycemia rate
timeFrame: 12 months
Secondary outcomes:
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Glucose control
timeFrame: 12 months
measure: Flash Glucose Monitoring treatment satisfaction
timeFrame: 12 months
measure: Safety of the device
timeFrame: 12 months
measure: Feasibility of the device
timeFrame: 12 months
measure: Feasibility of the device
timeFrame: 12 months
measure: Feasibility of the device
timeFrame: 12 months
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria
Study officials:
affiliation: Regione Emilia-Romagna
name: Riccardo Bonadonna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
citation: American Diabetes Association. 6. Glycemic Targets. Diabetes Care. 2017 Jan;40(Suppl 1):S48-S56. doi: 10.2337/dc17-S009. No abstract available.
citation: Miller KM, Beck RW, Bergenstal RM, Goland RS, Haller MJ, McGill JB, Rodriguez H, Simmons JH, Hirsch IB; T1D Exchange Clinic Network. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013 Jul;36(7):2009-14. doi: 10.2337/dc12-1770. Epub 2013 Feb 1.
citation: Hoss U, Budiman ES, Liu H, Christiansen MP. Feasibility of Factory Calibration for Subcutaneous Glucose Sensors in Subjects With Diabetes. J Diabetes Sci Technol. 2014 Jan;8(1):89-94. doi: 10.1177/1932296813511747. Epub 2014 Jan 1.
citation: Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technol Ther. 2015 Nov;17(11):787-94. doi: 10.1089/dia.2014.0378. Epub 2015 Jul 14.
citation: New JP, Ajjan R, Pfeiffer AF, Freckmann G. Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS). Diabet Med. 2015 May;32(5):609-17. doi: 10.1111/dme.12713. Epub 2015 Feb 20.
citation: Bonora B, Maran A, Ciciliot S, Avogaro A, Fadini GP. Head-to-head comparison between flash and continuous glucose monitoring systems in outpatients with type 1 diabetes. J Endocrinol Invest. 2016 Dec;39(12):1391-1399. doi: 10.1007/s40618-016-0495-8. Epub 2016 Jun 10.