Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| University of Minnesota | OTHER |
| University of Colorado, Denver | OTHER |
| University of Michigan |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol-treated | Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol |
| |
| Placebo-treated | Participants in the PERL Clinical Trial (NCT02017171) randomized to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mean blood glucose | Other | Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| iGFR at the end 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. | Week 164 of the PERL trial |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at week 80 of the PERL trial | Hba1c value at week 80 of the PERL trial | Week 80 of the PERL Trial |
| HbA1c at week 96 of the PERL trial | Hba1c value at week 96 of the PERL trial |
Not provided
Inclusion Criteria:
• Being an active participant in the PERL clinical trial
Exclusion Criteria:
Not provided
Not provided
Participants of the PERL Clinical Trial
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center / University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Emory University - Grady Memorial Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Northwestern University | OTHER |
| Albert Einstein College of Medicine | OTHER |
| Washington University School of Medicine | OTHER |
| University of Washington | OTHER |
| Providence Medical Research Center | OTHER |
Not provided
Not provided
Not provided
| 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 |
|
| Week 96 of the PERL Trial |
| HbA1c at week 112 of the PERL trial | Hba1c value at week 112 of the PERL trial | Week 112 of the PERL Trial |
| HbA1c at week 128 of the PERL trial | Hba1c value at week 128 of the PERL trial | Week 128 of the PERL Trial |
| HbA1c at week 142 of the PERL trial | Hba1c value at week 142 of the PERL trial | Week 142 of the PERL Trial |
| HbA1c at week 156 of the PERL trial | Hba1c value at week 156 of the PERL trial | Week 156 of the PERL Trial |
| HbA1c at week 164 of the PERL trial | Hba1c value at week 164 of the PERL trial | Week 164 of the PERL Trial |
| Mean blood glucose | Mean of blood glucose values measured by continuous glucose monitoring | From week 80 to week 164 of the PERL trial |
| CV (coefficient of variation) of blood glucose | Coefficient of variation of blood glucose values measured by continuous glucose monitoring | From week 80 to week 164 of the PERL trial |
| % time 70-180 mg/dL | Percentage 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 | Percentage 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 | Percentage 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 | Percentage 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) | Mean amplitude of glucose excursions as measured by continuous glucose monitoring | From week 80 to week 164 of the PERL trial |
| LBGI (Low blood glucose index) | Low blood glucose index based on blood glucose values measured by continuous glucose monitoring | From week 80 to week 164 of the PERL trial |
| HBGI (High blood glucose index) | High blood glucose index based on blood glucose values measured by continuous glucose monitoring | From week 80 to week 164 of the PERL trial |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Brehm Center for Diabetes Research / University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| ICAHN School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Albert Einstein College of Medicine / Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| UT Southwestern Dallas | Dallas | Texas | 75390 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Unversity of Calgary | Calgary | Alberta | T2T 5C7 | Canada |
| University of Alberta | Edmonton | Alberta | T6G2E1 | Canada |
| BC Diabetes | Vancouver | British Columbia | V5Y 3W2 | Canada |
| University of Toronto | Toronto | Ontario | M5T-3L9 | Canada |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013995 | Time |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided