PERL Continuous Glucose Monitoring (CGM) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

Study Description

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

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.

Study Design

Layout table for study information

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

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Allopurinol

U.S. FDA Resources

Groups and Cohorts

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

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

Outcome Measures

Primary Outcome Measures :

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 :

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
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
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
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
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
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
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
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
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
% 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)
% 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)
% 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)
% 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)
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
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
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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Contacts and Locations

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 19 study locations

Layout table for location information

United States, Colorado
Barbara Davis Center / University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University - Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Brehm Center for Diabetes Research / University of Michigan
Ann Arbor, Michigan, United States, 48105
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Albert Einstein College of Medicine / Montefiore Medical Center
Bronx, New York, United States, 10461
ICAHN School of Medicine at Mount Sinai
New York, New York, United States, 10029
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Texas
UT Southwestern Dallas
Dallas, Texas, United States, 75390
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Canada, Alberta
Unversity of Calgary
Calgary, Alberta, Canada, T2T 5C7
University of Alberta
Edmonton, Alberta, Canada, T6G2E1
Canada, British Columbia
BC Diabetes
Vancouver, British Columbia, Canada, V5Y 3W2
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5T-3L9

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

Layout table for investigator information

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

More Information

Layout table for additonal information

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

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

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

To Top