PERL Continuous Glucose Monitoring (CGM) Study

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.

Conditions

• Diabetic Nephropathies

Interventions

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

DRUG

Placebo

Oral placebo tablets administered in the PERL Clinical Trial

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Providence Medical Research Center

  collaborator OTHER

• Joslin Diabetes Center

  lead OTHER

Principal Investigators

• Alessandro Doria, MD PhD MPH · Joslin Diabetes Center

• Irl Hirsch, MD · University of Washington

• Janet McGill, MD · Washington University, St. Louis, MO

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2019-08-31

Completion

2021-12-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations