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PERL Continuous Glucose Monitoring (CGM) Study

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ClinicalTrials.gov Identifier: NCT03334318
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
University of Minnesota
University of Colorado, Denver
University of Michigan
Feinberg School of Medicine, Northwestern University
Albert Einstein College of Medicine
Washington University School of Medicine
University of Washington
Providence Medical Research Center
Information provided by (Responsible Party):
Alessandro Doria, Joslin Diabetes Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabetic Nephropathies Other: Mean blood glucose Other: Blood glucose CV Other: % time 70-180 mg/dL Other: % time below 54 mg/dL Other: % time above 180 mg/dL Other: % time above 250 mg/dL Other: MAGE (Mean amplitude of glucose excursions) Other: LBGI (Low Blood Glucose Index) Other: HBGI (High Blood Glucose Index) Drug: Allopurinol Drug: Placebo

Detailed Description:

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

  1. 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).
  2. 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.
  3. To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.
  4. To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.
  5. 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Allopurinol

Group/Cohort Intervention/treatment
Allopurinol-treated
Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol
Other: Mean blood glucose
Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

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

Other: % time 70-180 mg/dL
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.

Other: % time below 54 mg/dL
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.

Other: % time above 180 mg/dL
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.

Other: % time above 250 mg/dL
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.

Other: MAGE (Mean amplitude of glucose excursions)
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.

Other: LBGI (Low Blood Glucose Index)
Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Other: HBGI (High Blood Glucose Index)
High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Drug: Allopurinol
Oral allopurinol tablets administered in the PERL Clinical Trial

Placebo-treated
Participants in the PERL Clinical Trial (NCT02017171) randomized to placebo
Other: Mean blood glucose
Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

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

Other: % time 70-180 mg/dL
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.

Other: % time below 54 mg/dL
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.

Other: % time above 180 mg/dL
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.

Other: % time above 250 mg/dL
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.

Other: MAGE (Mean amplitude of glucose excursions)
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.

Other: LBGI (Low Blood Glucose Index)
Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Other: HBGI (High Blood Glucose Index)
High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.

Drug: Placebo
Oral placebo tablets administered in the PERL Clinical Trial




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants of the PERL Clinical Trial
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334318


Locations
Show Show 19 study locations
Sponsors and Collaborators
Joslin Diabetes Center
The Leona M. and Harry B. Helmsley Charitable Trust
University of Minnesota
University of Colorado, Denver
University of Michigan
Feinberg School of Medicine, Northwestern University
Albert Einstein College of Medicine
Washington University School of Medicine
University of Washington
Providence Medical Research Center
Investigators
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Principal Investigator: Alessandro Doria, MD PhD MPH Joslin Diabetes Center
Principal Investigator: Irl Hirsch, MD University of Washington
Principal Investigator: Janet McGill, MD Washington University, St. Louis, MO
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Responsible Party: Alessandro Doria, Senior Investigator, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT03334318    
Other Study ID Numbers: 2018PG-T1D014
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs