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Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
NA trial testing Continuous Glucose Monitoring in Diabetes in 80 participants. Completed in 21 August 2018.
| Lead sponsor | Northwell Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 30 November 2017 |
| Primary completion | 21 August 2018 |
| Estimated completion | 21 August 2018 |
| Sites | 1 location across United States |
Northwell Health — full company profile →
18 and older, any sex, with Diabetes or Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 151.5 | 75 – 405 |
Hypoglycemic event will be considered when blood sugar level is \<=70 mg/dl. Detail information like time of event, number of subjects with an event, duration of event will be analyzed.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 61 |
Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 7.5 | ± 9.0 |
As monitoring device measures blood glucose level numerous time, duration of hypoglycemic event will be calculated in percent time per subject based on total duration of time subject wore CGM device.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 7.5 | ± 10.1 |
HbA1c collected at end of the participation.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 7.2 | 4.8 – 13.2 |
Serum fructosamine (µmol/L) collected at the end of participation.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 304.1 | 177 – 523 |
Using blood glucose information measured with continuous blood glucose monitoring device, probable level of serum fructosamine (µmol/L) will be measured for each participant and mean will be analyzed.
| Group | Value | 95% CI |
|---|---|---|
| Continuous Glucose Monitoring | 304.1 | ± 57.2 |
Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing