
Giovanni Fazio
Triolo Zancla Hospital, ItalyTitle: HFpEF and glycemic variability: Can be really an incidence more then 60%? A clinical trial enrolled 100 patients tested by Glunovo® holter
Abstract
Background: The correlation between diabetic cardiomyopathy and diastolic dysfunction has been known for some time. Recently epidemiological studies have shown a correlation between heart failure with preserved ejection fraction (HFpEF) and duration of the disease, worse glycaemic control, the presence of diabetic retinopathy, neuropathy, and nephropathy. The ADA recommends using any of these four criteria for diabetes diagnosis Haemoglobin A1C ?6.5% or Fasting plasma glucose (FPG) ?126 mg/dL or random plasma glucose (PG) ?200 mg/dL.Glunovo® is a latest generation system for continuous blood glucose monitoring (CGM). It consists of a transdermal sensor that records the amount of glucose present in the interstitial fluid. The sensor electrode chemically reacts with glucose in the hypodermic fluid of the tissue to generate an electrical signal. The transmitter analyzes and calculates the electrical signal and generates blood glucose values, which are transmitted to the mobile app. The analytics software downloads and collects data from the mobile app for processing and analysis, then provides a report. The On-Demand Blood Glucose Monitoring System calculates an average blood glucose every three minutes. On-demand blood glucose monitoring systems monitors blood glucose data for 14 days and determines a blood glucose curve. In this study we used this monitoring system in patients with diastolic heart failure.
Purpose: In our study we evaluated the non diabetic patients with HFpEF with Glunovo® to evaluate the glycaemic variability in this population.
Methods: Consecutively, 100 subjects with diastolic heart failure who had been hospitalized to cardiology units at four Italian centers on the major islands were included. A total of 3360 punctual glucose readings in the abdominal interstitial fluid were taken for each patient while Glunovo® was used on them for seven days. The HFpEF diagnosis required three obligatory conditions had to be simultaneously satisfied: presence of signs or symptoms of congestive heart failure; presence left ventricular systolic function >55%; evidence of abnormal relaxation pattern of transmitral flow and an increased E/E’ ratio in tissue doppler of lateral left ventricular wall. At the conclusion of the glycaemic monitoring, each patient's glycaemic variability (GV) and incidence of hyper- and hypoglycaemia were analysed. A blood glucose level of more than 200 mg/dL or less than 59 mg/dL found more than three times each day for at least four days is referred to as having a high level of GV. The inclusion criterion was the presence of diastolic heart failure while the only exclusion criterion was the presence of diabetes diagnosis. A total of 57 women and 43 men, with a mean age of 69.3 years, were included (39-87 years). At the time of admission, all patients got a prompt glucose test that ruled out hyperglycaemia. During the hospital stay, no potentially hyperglycemic medications were added to the patient's regimen. The inpatient diagnostic protocol included CGM as a key component.
Results: It was possible to complete the analysis in 94 out of the 100 patients recruited, identifying the glycaemic variability, point glycaemia values, and estimated glycated haemoglobin value. 53 patients (56%) had glycaemic levels above 200 mg / dL, while 51 patients (54%) had significant GV. 48 individuals (54%) had blood glucose readings below 59 mg/dL. The predicted glycated Hb values were greater than 7% just five occasions. An oral glucose load curve was recommended for 32 of the patients who had at least three punctual glucose levels ?200 mg/dL, and it was 100% accurate in confirming the diagnosis of diabetes. Based on age group or sex, no statistically significant differences were observed. In the control group, consisting of 10 patients without HFpEF undergoing CGM at one of the participating cardiology units, an unknown hyperglycaemia was found in only one patient (10%) and a GV in another patient (10%).
Conclusions: In individuals with diastolic heart failure, our experience points to an incidence of hyperglycemia and glycaemic variability more than 65%. If our results were replicated on a wide-scale, the high frequency of diabetes in individuals with HFpEF could explain why SGLT-2 inhibitors and GLP-1 agonists are effective in treating this group of patients.
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