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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Flash Glucose Monitoring-FGM

• Registration Number: NCT04060732
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

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.

Study Timeline

• Study Start: 2017-05-05
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2020-01-31
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Severe hypoglycemia rate	12 months	Percentage (%) of patients with at least 1 episode of severe hypoglycemia.

Secondary Outcome Measures

Name	Time	Method
Safety of the device	12 months	Number (n) of allergic patch reactions.
Feasibility of the device	12 months	Number (n) of device interruptions.
Glucose control	12 months	Time spent in hyperglycemia (\>13.3 mmol/L) at any time of day.
Flash Glucose Monitoring treatment satisfaction	12 months	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.

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria; 🇮🇹 Parma, Italy