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DiabetesNCT03383627

Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease

A study testing Continuous Glucose Monitoring in people with Diabetes and Kidney Diseases, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Kidney Diseases
What is being tested?
Continuous Glucose Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
30 Nov 2017to 21 Aug 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • 18 years and older with ability to speak and understand English
  • Established diagnosis of type 2 Diabetes Mellitus
  • Chronic Kidney Disease (stages 3b, 4 or 5, eGFR (Glomerular Filtration Rate) < 45 ml/min, and not on dialysis) documented within 3 months of enrollment

Who cannot join

  • Type 2 Diabetes Mellitus.
  • Patient with End stage kidney disease on Dialysis.
  • Presence of Hemoglobinopathies.
  • Red blood cell transfusion in the last 12 weeks.
  • Hb < 9 g/dL documented within 3 months of enrollment - Dosing with an erythropoiesis stimulating agent is acceptable but dose must be stable for two months.
  • Use of acetaminophen on a daily basis.
Show all 9Show fewer
  • Systemic steroid treatment in the past 12 weeks.
  • Greater than 50% dose change in diabetes medications or new diabetes medications started in the previous 8 weeks.
  • Currently pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwell Health (Division Endocrinology and Nephrology)

    Great Neck, New York, 11021

Other trials in United States

About this study

Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.

Read the detailed description

In the proposed study Investigator plan to utilize CGM in patients with late stage CKD stages 3b-5 to 1) determine accuracy of HbA1c and serum fructosamine testing as measures of glucose control in patients with Type 2 Diabetes Mellitus (T2DM), 2) Better understand test characteristics in the late stage CKD population (correlation, linear equation, slope, Y intercept, average glucose at different HbA1c levels), 3) Develop a preliminary understanding of how test characteristics differ in late stage CKD compared to other patients with diabetes, 4) quantify time burden and number of episodes of hypoglycemia, 4) study hyperglycemic burden and 5) analyze glucose variability. The research staff will explain the study to patients that meet all inclusion criteria. Patients will get time to understand the study, review the consent document, ask questions to the PI, and then provide their consent to participate in the study. On Day 1 of the study, a CGM (Freestyle Libre) device will be placed on patients with CKD 3b-5 which will be worn for 14 consecutive days. Patients will return on Day 14 to remove the CGM device. HbA1c and fructosamine values will be drawn on Day 14 and these results will be compared with average glucose monitoring values as recorded on the CGM device. Incidence, duration, and severity of both hypoglycemic and hyperglycemic events will be analyzed. Investigators hypothesis that there will be significant variability in the serum HbA1c values when compared with calculated HbA1c from CGM readings. Investigators also hypothesize that the results will reflect a greater incidence of hypoglycemia in this population by CGM analysis.

Being tested
Continuous Glucose Monitoring
Keywords
Chronic Kidney Disease
Medical subject headings
Diabetes Mellitus, Kidney Diseases, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Glucose MonitoringDevice

    • The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The Freestyle Libre Pro device is FDA approved (PMA# P150021). Participants will use the FreeStyle Libre Pro Flash Glucose Monitoring device according to its approved use, on the back of the arm.
    • CGM monitoring will be performed on Day 1 by placing the Freestyle Libre Pro on research subjects for intended use of 14 days.
    • Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis.
Study groups in NCT03383627
Study groupRoleWhat they receive
Continuous glucose monitoringExperimental* If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring. * Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters. * There are no drug washout periods. Subjects will continue to take all their medications and/or insulins as prescribed by their doctor. * Baseline data including age, race, ethnicity, past medical history, home medication list, and diabetes related laboratory data will be collected.
Receives: Device: Continuous Glucose Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Glucose Concentration Measured by CGM

    Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.

    Measured: 14 Days

  2. Number of Participants With Hypoglycemic Events

    Hypoglycemic event will be considered when blood sugar level is <=70 mg/dl. Detail information like time of event, number of subjects with an event, duration of event will be analyzed.

    Measured: 14 Days

  3. Mean Number of Hypoglycemic Events Per Participant.

    Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed.

    Measured: 14 Days

  4. Duration Hypoglycemic Events

    As monitoring device measures blood glucose level numerous time, duration of hypoglycemic event will be calculated in percent time per subject based on total duration of time subject wore CGM device.

    Measured: 14 Days

  5. Mean HbA1c

    HbA1c collected at end of the participation.

    Measured: 14 Days

Secondary outcomes (2)

  1. Mean Serum Fructosamine Concentration

    Serum fructosamine (µmol/L) collected at the end of participation.

    Measured: 14 Days

  2. Determination of Serum Fructosamine

    Using blood glucose information measured with continuous blood glucose monitoring device, probable level of serum fructosamine (µmol/L) will be measured for each participant and mean will be analyzed.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start30 Nov 2017
  3. Primary completion21 Aug 2018
  4. Study completion21 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383627
Sponsor's protocol ID
17-0531
Status last verified
Mar 2021
First submitted
30 Oct 2017
Last updated
6 Apr 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Access to study data will be limited to Institutional Review Board (IRB) approved personnel only.

Publications

  • Miedema K. Standardization of HbA1c and Optimal Range of Monitoring. Scand J Clin Lab Invest Suppl. 2005;240:61-72. doi: 10.1080/00365510500236143.

    PubMed 16112961

  • Rabkin R, Ryan MP, Duckworth WC. The renal metabolism of insulin. Diabetologia. 1984 Sep;27(3):351-7. doi: 10.1007/BF00304849.

    PubMed 6389240

  • Castellino P, DeFronzo RA. Glucose metabolism and the kidney. Semin Nephrol. 1990 Sep;10(5):458-63.

    PubMed 2236987

  • Dolscheid-Pommerich RC, Kirchner S, Weigel C, Eichhorn L, Conrad R, Stoffel-Wagner B, Zur B. Impact of carbamylation on three different methods, HPLC, capillary electrophoresis and TINIA of measuring HbA1c levels in patients with kidney disease. Diabetes Res Clin Pract. 2015 Apr;108(1):15-22. doi: 10.1016/j.diabres.2015.01.034. Epub 2015 Jan 29.

    PubMed 25684605

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Glucose Monitoring in people with Diabetes and Kidney Diseases, run by Northwell Health at 1 site in United States.

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 3 inclusion and 9 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 6 Apr 2021. 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 United States. 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?

Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Glucose Concentration Measured by CGM (time frame: 14 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383627, which also lists 4 linked publications.

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 6 Apr 2021.

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