Continuous glucose monitoring with FreeStyle Libre PRO sensor in patients with type 2 diabetes and end-stage renal failure on haemoDIALysis (FSLPRO-DIAL pilot study)

Zoé Henry; Emmanuel Villar; Cécile Chauvet; Amélie Belloi; Ionut Prunescu; Fanny Doroszewski; Cédric Luyton; Lucien Marchand

doi:10.1007/s00592-024-02323-z

Continuous glucose monitoring with FreeStyle Libre PRO sensor in patients with type 2 diabetes and end-stage renal failure on haemoDIALysis (FSLPRO-DIAL pilot study)

Acta Diabetol. 2024 Jun 26. doi: 10.1007/s00592-024-02323-z. Online ahead of print.

Authors

Zoé Henry¹, Emmanuel Villar^#^{2

3}, Cécile Chauvet², Amélie Belloi², Ionut Prunescu², Fanny Doroszewski³, Cédric Luyton¹, Lucien Marchand^#⁴

Affiliations

¹ Service de Diabétologie et d'Endocrinologie, Hôpital Saint Joseph Saint Luc, 20 Quai Claude Bernard, 69007, Lyon, France.
² Service de Néphrologie, Hôpital Saint Joseph Saint Luc, 20 Quai Claude Bernard, 69007, Lyon, France.
³ Unité de Recherche Clinique, Hôpital Saint Joseph Saint Luc, 20 Quai Claude Bernard, 69007, Lyon, France.
⁴ Service de Diabétologie et d'Endocrinologie, Hôpital Saint Joseph Saint Luc, 20 Quai Claude Bernard, 69007, Lyon, France. lmarchand@saintjosephsaintluc.fr.

^# Contributed equally.

PMID: 38922428
DOI: 10.1007/s00592-024-02323-z

Abstract

Aims: For end-stage renal disease (ESRD) patients with diabetes on haemodialysis, diabetes control is difficult to achieve. Hypoglycaemia is a major problem in these frailty subjects. Continuous glucose monitoring (CGM) devices appear therefore to be a good tool to help patients monitor their glycaemic control and to help practitioners optimize treatment. We aimed to compare the laboratory value of Hba1c with the sensor-estimated value of Hba1c (= glucose management indicator, GMI) in ESRD patients with type 2 diabetes (T2D) (with or without insulin treatment) on haemodialysis. Secondly, we aimed to identify CGM-derived monitoring parameters [time in range, time in hypo/hyperglycaemia, glycaemic variability (coefficient of variation, CV)] to identify patients at risk of frequent hypo- or hyperglycaemia.

Methods: The FSLPRO-DIAL pilot study (NCT04641650) was a prospective monocentric cohort study including 29 subjects with T2D who achieve the protocol. Inclusion criteria were: age ≥ 18 years, haemodialysis duration for at least 3 months, type 2 diabetes with no change in treatment for at least 3 months. Demographic data and blood sample were collected at the day of inclusion. Freestyle Libre pro IQ sensor (blinded CGM) was inserted for 14 days. After this period, all CGMs data were collected and analysed.

Results: Data were available for 27 patients. Mean age was 73 ± 10, mean BMI 27.2 kg/m², mean duration of diabetes 16.9 years and mean dialysis duration 2.9 years. Twenty-four subjects were treated with insulin. Mean HbA1c was 6.6% (SD 1.2), and mean GMI was 6.7% (SD 0.9) (no significant difference, p = 0.3). Twelve subjects (44.4%) had a discordance between HbA1c and GMI of < 0.5%, 11 (40.8%) had a discordance between 0.5 and 1%, and only 4 (14.8%) had a discordance of > 1%. Mean time in range (70-180 mg/dl) was 71.9%, mean time below range (< 70 mg/dl) was 5.6%, and mean time above range (> 180 mg/dl) was 22.1%. Mean CV was 31.8%. For 13 out of 27 patients, we reduced antidiabetic treatment by stopping treatments or reducing insulin doses.

Conclusion: In this pilot study, there was no global significant difference between HbA1c and GMI in this particular cohort with very well-controlled diabetes. However, the use of the sensor enabled us to identify an excessive time in hypoglycemia in this fragile population and to adapt their treatment.

Keywords: Continuous glucose monitoring (CGM); Freestyle Libre pro IQ; Glucose Management Indicator (GMI); Glycaemic control; Haemodialysis; HbA1c; Hypoglycaemia; Type 2 diabetes.