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

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

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:

• EPO treatment is associated with an increase in the proportion of young érythrocytes
• reduction 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.

Study Overview

• Status: Completed
• Conditions: Diabetic

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients with dialysis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diabetic subjects under dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the time in range glycemic profile	Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis	12 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Ariane SULTAN, PR, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: peritoneal dialysis; haemodialysis; continuous glucose monitoring system
• Other Study ID Numbers: RECHMPL19_0586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No