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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060732
• Other study ID #: 44771
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Flash Glucose Monitoring-FGM
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria	Parma

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma	Regione Emilia-Romagna

Country where clinical trial is conducted

Italy, 

References & Publications (7)

American Diabetes Association. 6. Glycemic Targets. Diabetes Care. 2017 Jan;40(Suppl 1):S48-S56. Review. Erratum in: Diabetes Care. 2017 Jul;40(7):985. — View 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. — View 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. Epub 2016 Jun 10. — View 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. — View 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. Epub 2014 Jan 1. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severe hypoglycemia rate	Percentage (%) of patients with at least 1 episode of severe hypoglycemia.	12 months
Secondary	Glucose control	HbA1c (mmol/mol) change from baseline.	12 months
Secondary	Glucose control	Time in hypoglycemia (<3.9 mmol/L) at any time of day.	12 months
Secondary	Glucose control	Time spent with hypoglycemia (<3.1 mmol/L) at any time of day.	12 months
Secondary	Glucose control	Time spent with hypoglycemia (<2.2 mmol/L) at any time of day.	12 months
Secondary	Glucose control	Time spent within the euglycemic range (3.9 - 9.9 mmol/L) at any time of day.	12 months
Secondary	Glucose control	Time spent with hyperglycemia (>10 mmol/L)at any time of day.	12 months
Secondary	Glucose control	Time spent in hyperglycemia (>13.3 mmol/L) at any time of day.	12 months
Secondary	Flash Glucose Monitoring treatment satisfaction	Change in Diabetes Quality Of Life- DQOL score from baseline.; The original DQOL is a 60-item instrument to assess the diabetes-related QOL of participants. The instrument provides an overall scale score, as well as four subscale scores for 1) satisfaction with treatment, 2) impact of treatment, 3) worry about the future effects of diabetes, and 4) worry about social/vocational issues.; Items are scored on a 5-point Likert scale and are of two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment and provides response options from 1 (never) to 5 (all the time). The second format asks about satisfaction with treatment and quality of life and is scored from 1 (very satisfied) to 5 (very dissatisfied).; Higher scores on DQOL items and subscales are, therefore, negatively valenced, indicating problem frequency or dissatisfaction.	12 months
Secondary	Safety of the device	Number (n) of allergic patch reactions.	12 months
Secondary	Feasibility of the device	Number (n) of untimely detachments of the device.	12 months
Secondary	Feasibility of the device	Percentage (%) of recorded data by the device.	12 months
Secondary	Feasibility of the device	Number (n) of device interruptions.	12 months

External Links

•   IMPACT Study, Libre in T1DM reduces Hypoglycemia, Better Life Quality.