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Clinical Trial NCT03334318 for Diabetic Nephropathies is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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PERL Continuous Glucose Monitoring (CGM) Study 175
Clinical Trial NCT03334318 was an observational study for Diabetic Nephropathies that is now completed. The study started on 1 October 2017, with plans to enroll 175 participants. Led by Joslin Diabetes Center, the expected completion date was 31 December 2021. The latest data from ClinicalTrials.gov was last updated on 29 March 2022.
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 ...Show More
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...Show More
Official Title
PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study
Conditions
Diabetic NephropathiesOther Study IDs
- 2018PG-T1D014
NCT ID Number
Start Date (Actual)
2017-10-01
Last Update Posted
2022-03-29
Completion Date (Estimated)
2021-12-31
Enrollment (Estimated)
175
Study Type
Observational
Status
Completed
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Allopurinol-treated Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol | Mean blood glucose Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial. 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. % 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. % 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. % 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. % 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. 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. 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. 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. Allopurinol Oral allopurinol tablets administered in the PERL Clinical Trial |
Placebo-treated Participants in the PERL Clinical Trial (NCT02017171) randomized to placebo | Mean blood glucose Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial. 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. % 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. % 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. % 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. % 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. 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. 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. 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. Placebo Oral placebo tablets administered in the PERL Clinical Trial |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 | 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
• Being an active participant in the PERL clinical trial
- Having completed PERL Visit 16
- Pregnancy
- History of skin reactions in relation to the application of Abbott Freestyle Libre Pro
Joslin Diabetes CenterStudy Responsible Party
Alessandro Doria, Principal Investigator, Senior Investigator, Joslin Diabetes Center
No contact data.
19 Study Locations in 2 Countries
Colorado
Barbara Davis Center / University of Colorado Denver, Aurora, Colorado, 80045, United States
Georgia
Emory University - Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Illinois
Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611, United States
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
Michigan
Brehm Center for Diabetes Research / University of Michigan, Ann Arbor, Michigan, 48105, United States
Henry Ford Health System, Detroit, Michigan, 48202, United States
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States
Missouri
Washington University, St Louis, Missouri, 63110, United States
New York
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
Texas
UT Southwestern Dallas, Dallas, Texas, 75390, United States
Washington
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
Alberta
Unversity of Calgary, Calgary, Alberta, T2T 5C7, Canada
University of Alberta, Edmonton, Alberta, T6G2E1, Canada
British Columbia
BC Diabetes, Vancouver, British Columbia, V5Y 3W2, Canada
Ontario
University of Toronto, Toronto, Ontario, M5T-3L9, Canada