DiabeticNCT04288050
Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre
An observational study of Diabetic, run by University Hospital, Montpellier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2020to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients with dialysis
Who may be able to join
- Subjects over 18 years of age
- dialysis patients
- diabetics (any diabetes)
- any anti-diabetic treatment
- no objection form
Who cannot join
- Objection of the subject
- Subject under guardianship or tutelage
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
Read more
- 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.
Read the 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.
- Conditions
- Diabetic
- Keywords
- continuous glucose monitoring system, haemodialysis, peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic subjects under dialysis | Diabetic subjects under dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the time in range glycemic profile
Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis
Measured: 12 month
Secondary outcomes (7)
Time above range of glycemic target
Time above range of glycemic target
Measured: 6 month
Time below range of glycemic target
Time below range of glycemic target
Measured: 6 month
Glucose management Indicator
Glucose management Indicator
Measured: 6 month
Number of hypoglycemic events
Number of hypoglycemic events
Measured: 6 month
mean number of scans on diabetic subjects in Dialysis.
mean number of scans on diabetic subjects in Dialysis.
Measured: 6 month
Evaluate the Delta between measured HbA1c and GMI.
Evaluate the Delta between measured HbA1c and GMI.
Measured: 6 month
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start16 Jan 2020
- Primary completion1 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane SULTAN, PR, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288050
- Sponsor's protocol ID
- RECHMPL19_0586
- Status last verified
- Jun 2020
- First submitted
- 4 Dec 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04288050
- Acronym / sponsor ID
- RECHMPL19_0586
- Conditions
- Diabetic
- Keywords
- continuous glucose monitoring system, haemodialysis, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic subjects under dialysis | – | –Diabetic subjects under dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with dialysis
Key inclusion criteria (5 listed)
- Subjects over 18 years of age
- dialysis patients
- diabetics (any diabetes)
- any anti-diabetic treatment
- no objection form
Key exclusion criteria (2 listed)
- Objection of the subject
- Subject under guardianship or tutelage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the time in range glycemic profile
Time frame: 12 month
Evaluate the time in range glycemic profile in diabetic patients undergoing dialysis
7 secondary outcomes
Time above range of glycemic target
Time frame: 6 month
Time below range of glycemic target
Time frame: 6 month
Glucose management Indicator
Time frame: 6 month
Number of hypoglycemic events
Time frame: 6 month
mean number of scans on diabetic subjects in Dialysis.
Time frame: 6 month
Evaluate the Delta between measured HbA1c and GMI.
Time frame: 6 month
Evaluate the correlation between average interstitial glucose measured at Freestyle and measured HbA1c.
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariane SULTAN, PR study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the time in range glycemic profile (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.