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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Flash Glucose Monitoring-FGM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Flash Glucose Monitoring Device<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose control | HbA1c (mmol/mol) change from baseline. | 12 months | 
| Glucose control | Time in hypoglycemia (<3.9 mmol/L) at any time of day. | 12 months | 
| Glucose control | Time spent with hypoglycemia (<3.1 mmol/L) at any time of day. | 12 months | 
| Glucose control | Time spent with hypoglycemia (<2.2 mmol/L) at any time of day. | 12 months | 
| Glucose control | Time spent within the euglycemic range (3.9 - 9.9 mmol/L) at any time of day. | 12 months | 
| Glucose control | Time spent with hyperglycemia (>10 mmol/L)at any time of day. | 12 months | 
| Glucose control | Time spent in hyperglycemia (>13.3 mmol/L) at any time of day. | 12 months | 
| 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 | 
| Safety of the device | Number (n) of allergic patch reactions. | 12 months | 
| Feasibility of the device | Number (n) of untimely detachments of the device. | 12 months | 
| Feasibility of the device | Percentage (%) of recorded data by the device. | 12 months | 
| Feasibility of the device | Number (n) of device interruptions. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flash Glucose Monitoring, Glucose Monitoring, Diabetes Mellitus Type 1