Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.

NCT04060732 | Completed

• 1 other identifier: 44771
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Flash Glucose Monitoring; Glucose Monitoring; Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (2)

• Severe hypoglycemia rate

  Frequency (number) of serious episodes of hypoglycemia (as defined by the American Diabetes Association, as severe cognitive impairment requiring external assistance for recovery).

  12 months

• Severe hypoglycemia rate

  Percentage (%) of patients with at least 1 episode of severe hypoglycemia.

  12 months

Secondary Outcomes (12)

• Glucose control

  12 months

• Glucose control

  12 months

• Glucose control

  12 months

• Glucose control

  12 months

• Glucose control

  12 months

Study Arms (1)

Flash Glucose Monitoring Device

The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" used by Diabetes Mellitus type 1 patients.

Device: Flash Glucose Monitoring-FGM

Interventions

Flash Glucose Monitoring-FGM DEVICE

The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" will be assigned to the enrolled patients at baseline until the end of follow-up after 12 months.

Flash Glucose Monitoring Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• Regione Emilia-Romagna: collaborator

Study Sites (1)

Azienda Ospedaliero Universitaria

Parma, 43100, Italy

Location

Related Publications (8)

• 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.

  PMID: 8366922 BACKGROUND

• American Diabetes Association. 6. Glycemic Targets. Diabetes Care. 2017 Jan;40(Suppl 1):S48-S56. doi: 10.2337/dc17-S009. No abstract available.

  PMID: 27979893 BACKGROUND

• 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.

  PMID: 23378621 BACKGROUND

• 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.

  PMID: 24876543 BACKGROUND

• 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.

  PMID: 26171659 BACKGROUND

• 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.

  PMID: 25661981 BACKGROUND

• 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.

  PMID: 27287421 BACKGROUND

• Dei Cas A, Aldigeri R, Bellei G, Raffaeli D, Di Bartolo P, Sforza A, Marchesini G, Ciardullo AV, Manicardi V, Bianco M, Monesi M, Vacirca A, Cimicchi MC, Sordillo PA, Altini M, Fantuzzi F, Bonadonna RC; Flash-glucose monitoring Emilia Romagna Regional network. Effectiveness of the flash glucose monitoring system in preventing severe hypoglycemic episodes and in improving glucose metrics and quality of life in subjects with type 1 diabetes at high risk of acute diabetes complications. Acta Diabetol. 2024 Sep;61(9):1177-1184. doi: 10.1007/s00592-024-02298-x. Epub 2024 Jun 4.

  PMID: 38833007 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Riccardo Bonadonna, MD

  Regione Emilia-Romagna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology and Metabolic disease Unit

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 19, 2019
• Study Start: May 5, 2017
• Primary Completion: January 31, 2020
• Study Completion: December 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

IT (1)