Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre

Overview

In France, chronic end-stage renal disease affects more than 11,000 new patients each year who will require dialysis or renal transplantation, of whom approximately 22.6% of new cases are related to diabetes. Among them, about 94% are managed by hemodialysis (HD), the others by peritoneal dialysis (PD). In addition, nearly 42% of dialysis patients have diabetes. There are issues related to glycemic control during dialysis and specific to each dialysis technique. Thus, hypoglycemic risk is the main risk observed during hemodialysis sessions, linked in particular to the use of a 1g/L glucose free dialysate, a decrease in renal neoglucogenesis and alterations in metabolic pathways. In addition, long-term glycemic control is difficult to assess in dialysis patients, because of the limitations of HbA1c witch is frequently underestimated. This can be explained by 2 mechanisms: РEPO treatment is associated with an increase in the proportion of young érythrocytes Рreduction in the lifetime of red blood cells reducing the duration of interaction between glucose and hemoglobin. The results of studies conducted using continuous glucose measurements over a short period of time (48 hours to 5 days) suggest a benefit in using continuous glucose measurement to detect glycemic fluctuations during dialysis. To our knowledge, no studies have been conducted to evaluate longer-term glycemic control with this technology. In addition, the investigators now have the Freestyle, which allows us to record the continuous measurement of interstitial glucose over a longer period of time and is reimbursed for people on insulin basal-bolus protocol. Thus, the investigators propose an observational study to evaluate glycemic control during dialysis sessions, but also to analyze the correlation between parameters measured with Freestyle and HbA1c measured routinely, according to the follow-up recommendations in diabetics.

Full Title of Study: “Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre. Observational Prospective Study Without Modification of Management.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2020

Detailed Description

Data : patient data (clinical, biological and additional examinations) on a database registered at the University Hospital of Montpellier, on the secure server. – Computerized medical records (DXcare) and consultation letters. – Analysis of Freestyle data on a dedicated Freestyle View software, after downloading data on this software Demographic characteristics: Age, gender Clinical history: Older diabetes, presence of diabetic retinopathy, diabetic maculopathy, microalbuminuria or proteinuria, older dialysis, type of dialysis, presence of ischemic heart disease, history of stroke, arteriopathy, gastroparesis, diabetic neuropathy, high blood pressure, hypercholesterolemia. Treatments: diabetes, type of kidney replacement, other treatments Biological assessment: Creatinemia, DFG, microalbuminuria, HbA1C, Hemoglobinemia, HDL, LDL, triglyceridemia, cholesterol, albuminuria/creatinuria ratio, proteinuria/creatinuria ratio Patients will sign a non-opposition form.

Arms, Groups and Cohorts

  • Diabetic subjects under dialysis
    • Diabetic subjects under dialysis

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate the time in range glycemic profile
    • Time Frame: 12 month
    • Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis

Secondary Measures

  • Time above range of glycemic target
    • Time Frame: 6 month
    • Time above range of glycemic target
  • Time below range of glycemic target
    • Time Frame: 6 month
    • Time below range of glycemic target
  • Glucose management Indicator
    • Time Frame: 6 month
    • Glucose management Indicator
  • Number of hypoglycemic events
    • Time Frame: 6 month
    • Number of hypoglycemic events
  • mean number of scans on diabetic subjects in Dialysis.
    • Time Frame: 6 month
    • mean number of scans on diabetic subjects in Dialysis.
  • Evaluate the Delta between measured HbA1c and GMI.
    • Time Frame: 6 month
    • Evaluate the Delta between measured HbA1c and GMI.
  • Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.
    • Time Frame: 6 month
    • Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects over 18 years of age – dialysis patients – diabetics (any diabetes) – any anti-diabetic treatment – no objection form Exclusion criteria:
  • Objection of the subject – Subject under guardianship or tutelage
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University Hospital, Montpellier
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Ariane SULTAN, PR, Study Director, University Hospital, Montpellier

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