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Completed

NCT Number: NCT03334318

PERL Continuous Glucose Monitoring (CGM) Study

Seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. However, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. The PERL trial (NCT02017171), testing whether treatment with allopurinol can slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess the role of glycemic variability in the progression of diabetic kidney disease in individuals who already have mild to moderate kidney disease. By applying Continuous Glucose Monitoring (CGM) in the PERL Study population, the investigators will be able to better understand how metrics of glycemia (mean, time above and below range, and various measures of variability) are associated with renal outcomes in the PERL population as a whole, but also in important subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing GFR decline, allopurinol vs. placebo arms). The nvestigators also aim to obtain precise information on the range of blood glucose corresponding to any given HbA1c value in this population since previous studies generally excluded patients with renal disease.

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Key information

Conditions

Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unversity of Calgary, Calgary, Alberta, Canada

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About this study

Participants who consent to the study will have an Abbott Freestyle Libre Pro sensor placed on the back of their upper arm at their first PERL visit after this ancillary study has begun and at all subsequent PERL Visits. The sensor will be continuously worn by participants for 14 days. At the end of the 14 days, the sensor will be removed and mailed by the participant to the Coordinating center. Since subjects are at various stages of the PERL protocol, the number of remaining visits at which the CGM will be applied will vary among subjects.

STUDY AIMS

  • To assess the effect of glycemic variability, as measured by the coefficient of variation of CGM glucose (CV, the ratio of standard deviation and the mean of CGM glucose values), on the PERL renal functional endpoint (iohexol GFR at the end of study).
  • To assess the effect of other glycemic parameters measured by CGM (mean glucose, % time 70-180 mg/dL, % time below 54 mg/dL, % time below 70 mg/dL, % time above 180 mg/dL, % time above 250 mg/dL, mean amplitude of glucose excursions [MAGE], low blood glucose index [LBGI], high blood glucose index [HBGI]) on the PERL renal functional endpoint.
  • To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.
  • To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.
  • To assess the effect of allopurinol treatment on all of the different glycemic metrics including HbA1c, CV, etc. and on their association with the PERL renal endpoint.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being an active participant in the PERL clinical trial

Exclusion criteria

  • Having completed PERL Visit 16
  • Pregnancy
  • History of skin reactions in relation to the application of Abbott Freestyle Libre Pro

Treatment and study plan

Mean blood glucose

Other

Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Blood glucose CV

Other

Coefficient of variation of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

% time 70-180 mg/dL

Other

Percent of time with blood glucose in the 70-180 mg/dL range as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

% time below 54 mg/dL

Other

Percent of time with blood glucose below 54 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

% time above 180 mg/dL

Other

Percent of time with blood glucose above 180 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

% time above 250 mg/dL

Other

Percent of time with blood glucose above 250 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

MAGE (Mean amplitude of glucose excursions)

Other

Mean amplitude of glucose excursions as measured by continuous glucose monitoring as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

LBGI (Low Blood Glucose Index)

Other

Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

HBGI (High Blood Glucose Index)

Other

High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Allopurinol

Drug

Oral allopurinol tablets administered in the PERL Clinical Trial

Placebo

Drug

Oral placebo tablets administered in the PERL Clinical Trial

Primary outcomes

  1. iGFR at the end of the PERL trial

    Time frame: Week 164 of the PERL trial

    Glomerular filtration rate (GFR) at the end of the PERL trial, measured by the plasma clearance of non-radioactive iohexol (iGFR) and adjusted for the iGFR at baseline.

Secondary outcomes

  1. HbA1c at week 80 of the PERL trial

    Time frame: Week 80 of the PERL Trial

    Hba1c value at week 80 of the PERL trial

  2. HbA1c at week 96 of the PERL trial

    Time frame: Week 96 of the PERL Trial

    Hba1c value at week 96 of the PERL trial

  3. HbA1c at week 112 of the PERL trial

    Time frame: Week 112 of the PERL Trial

    Hba1c value at week 112 of the PERL trial

  4. HbA1c at week 128 of the PERL trial

    Time frame: Week 128 of the PERL Trial

    Hba1c value at week 128 of the PERL trial

  5. HbA1c at week 142 of the PERL trial

    Time frame: Week 142 of the PERL Trial

    Hba1c value at week 142 of the PERL trial

  6. HbA1c at week 156 of the PERL trial

    Time frame: Week 156 of the PERL Trial

    Hba1c value at week 156 of the PERL trial

  7. HbA1c at week 164 of the PERL trial

    Time frame: Week 164 of the PERL Trial

    Hba1c value at week 164 of the PERL trial

  8. Mean blood glucose

    Time frame: From week 80 to week 164 of the PERL trial

    Mean of blood glucose values measured by continuous glucose monitoring

  9. CV (coefficient of variation) of blood glucose

    Time frame: From week 80 to week 164 of the PERL trial

    Coefficient of variation of blood glucose values measured by continuous glucose monitoring

  10. % time 70-180 mg/dL

    Time frame: From week 80 to week 164 of the PERL trial

    Percentage of time with blood glucose in the 70-180 mg/dL range (as measured by continuous glucose monitoring)

  11. % time below 54 mg/dL

    Time frame: From week 80 to week 164 of the PERL trial

    Percentage of time with blood glucose below 54 mg/dL (as measured by continuous glucose monitoring)

  12. % time above 180 mg/dL

    Time frame: From week 80 to week 164 of the PERL trial

    Percentage of time with blood glucose above 180 mg/dL (as measured by continuous glucose monitoring)

  13. % time above 250 mg/dL

    Time frame: From week 80 to week 164 of the PERL trial

    Percentage of time with blood glucose above 250 mg/dL (as measured by continuous glucose monitoring)

  14. MAGE (Mean amplitude of glucose excursions)

    Time frame: From week 80 to week 164 of the PERL trial

    Mean amplitude of glucose excursions as measured by continuous glucose monitoring

  15. LBGI (Low blood glucose index)

    Time frame: From week 80 to week 164 of the PERL trial

    Low blood glucose index based on blood glucose values measured by continuous glucose monitoring

  16. HBGI (High blood glucose index)

    Time frame: From week 80 to week 164 of the PERL trial

    High blood glucose index based on blood glucose values measured by continuous glucose monitoring

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Albert Einstein College of Medicine
  • Northwestern University
  • Providence Medical Research Center
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • University of Colorado, Denver
  • University of Michigan
  • University of Minnesota
  • University of Washington
  • Washington University School of Medicine

Registry information

Official study title

PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Nov 7, 2017
Registry last updated
Mar 29, 2022

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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