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NCT Number: NCT04288050

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

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.

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Key information

Conditions

Diabetic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate the time in range glycemic profile

    Time frame: 12 month

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

Secondary outcomes

  1. Time above range of glycemic target

    Time frame: 6 month

    Time above range of glycemic target

  2. Time below range of glycemic target

    Time frame: 6 month

    Time below range of glycemic target

  3. Glucose management Indicator

    Time frame: 6 month

    Glucose management Indicator

  4. Number of hypoglycemic events

    Time frame: 6 month

    Number of hypoglycemic events

  5. mean number of scans on diabetic subjects in Dialysis.

    Time frame: 6 month

    mean number of scans on diabetic subjects in Dialysis.

  6. Evaluate the Delta between measured HbA1c and GMI.

    Time frame: 6 month

    Evaluate the Delta between measured HbA1c and GMI.

  7. Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.

    Time frame: 6 month

    Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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