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

Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288050
• Other study ID #: RECHMPL19_0586
• Status: Completed
• Start date: January 16, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the time in range glycemic profile	Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis	12 month
Secondary	Time above range of glycemic target	Time above range of glycemic target	6 month
Secondary	Time below range of glycemic target	Time below range of glycemic target	6 month
Secondary	Glucose management Indicator	Glucose management Indicator	6 month
Secondary	Number of hypoglycemic events	Number of hypoglycemic events	6 month
Secondary	mean number of scans on diabetic subjects in Dialysis.	mean number of scans on diabetic subjects in Dialysis.	6 month
Secondary	Evaluate the Delta between measured HbA1c and GMI.	Evaluate the Delta between measured HbA1c and GMI.	6 month
Secondary	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