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

NCT04288050 | Completed

• 1 other identifier: RECHMPL19_0586
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic

Keywords

continuous glucose monitoring system; haemodialysis; peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Evaluate the time in range glycemic profile

  Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis

  12 month

Secondary Outcomes (7)

• Time above range of glycemic target

  6 month

• Time below range of glycemic target

  6 month

• Glucose management Indicator

  6 month

• Number of hypoglycemic events

  6 month

• mean number of scans on diabetic subjects in Dialysis.

  6 month

Study Arms (1)

Diabetic subjects under dialysis

Diabetic subjects under dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients with dialysis

You may qualify if:

• Subjects over 18 years of age
• dialysis patients
• diabetics (any diabetes)
• any anti-diabetic treatment
• no objection form

You may not qualify if:

• Objection of the subject
• Subject under guardianship or tutelage

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Ariane SULTAN, PR

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: February 27, 2020
• Study Start: January 16, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 30, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

FR (1)