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Completed

NCT Number: NCT04060732

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria

Parma, 43100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Severe hypoglycemia rate

    Time frame: 12 months

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

  2. Severe hypoglycemia rate

    Time frame: 12 months

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

Secondary outcomes

  1. Glucose control

    Time frame: 12 months

    HbA1c (mmol/mol) change from baseline.

  2. Glucose control

    Time frame: 12 months

    Time in hypoglycemia (<3.9 mmol/L) at any time of day.

  3. Glucose control

    Time frame: 12 months

    Time spent with hypoglycemia (<3.1 mmol/L) at any time of day.

  4. Glucose control

    Time frame: 12 months

    Time spent with hypoglycemia (<2.2 mmol/L) at any time of day.

  5. Glucose control

    Time frame: 12 months

    Time spent within the euglycemic range (3.9 - 9.9 mmol/L) at any time of day.

  6. Glucose control

    Time frame: 12 months

    Time spent with hyperglycemia (>10 mmol/L)at any time of day.

  7. Glucose control

    Time frame: 12 months

    Time spent in hyperglycemia (>13.3 mmol/L) at any time of day.

  8. Flash Glucose Monitoring treatment satisfaction

    Time frame: 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.

  9. Safety of the device

    Time frame: 12 months

    Number (n) of allergic patch reactions.

  10. Feasibility of the device

    Time frame: 12 months

    Number (n) of untimely detachments of the device.

  11. Feasibility of the device

    Time frame: 12 months

    Percentage (%) of recorded data by the device.

  12. Feasibility of the device

    Time frame: 12 months

    Number (n) of device interruptions.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Collaborators

  • Regione Emilia-Romagna

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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