Clinical trial NCT04288050: Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic
Keywords: continuous glucose monitoring system
haemodialysis
peritoneal dialysis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients with dialysis

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the time in range glycemic profile
timeFrame: 12 month
Secondary outcomes:
measure: Time above range of glycemic target
timeFrame: 6 month
measure: Time below range of glycemic target
timeFrame: 6 month
measure: Glucose management Indicator
timeFrame: 6 month
measure: Number of hypoglycemic events
timeFrame: 6 month
measure: mean number of scans on diabetic subjects in Dialysis.
timeFrame: 6 month
measure: Evaluate the Delta between measured HbA1c and GMI.
timeFrame: 6 month
measure: Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.
timeFrame: 6 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Ariane SULTAN, PR
role: STUDY_DIRECTOR
References: