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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04288050
Enrollment
80
Registered
2020-02-27
Start date
2020-01-16
Completion date
2020-05-30
Last updated
2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic

Keywords

continuous glucose monitoring system, haemodialysis, peritoneal 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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the time in range glycemic profile12 monthEvaluate the time in range glycemic profile in diabetic patients undergoing dialysis

Secondary

MeasureTime frameDescription
Time below range of glycemic target6 monthTime below range of glycemic target
Glucose management Indicator6 monthGlucose management Indicator
Number of hypoglycemic events6 monthNumber of hypoglycemic events
Time above range of glycemic target6 monthTime above range of glycemic target
Evaluate the Delta between measured HbA1c and GMI.6 monthEvaluate the Delta between measured HbA1c and GMI.
Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.6 monthEvaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.
mean number of scans on diabetic subjects in Dialysis.6 monthmean number of scans on diabetic subjects in Dialysis.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026