Trial · NCT06613854
Registered outcomes63
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 63
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time in Range (TIR) | Period of 14 days prior to last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Absolute Change in Time in Range (TIR) | Baseline (week 0) and last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Absolute Change in Glycated hemoglobin (HbA1c) | Baseline (week 0) and last study visit (week 26) | Assessment by biochemical methods (in %) |
| Secondary | Time above Range (TAR) | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 10.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time below Range (TBR) | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time above Range (TAR) - Level 1 Hyperglycemia | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 10.1-13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time above Range (TAR) - Level 2 Hyperglycemia | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is above 13.9 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time below Range (TBR) - Level 1 Hypoglycemia | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.0-3.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time below Range (TBR) - Level 2 Hypoglycemia | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is below 3.0 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Time in Tight Range (TITR) | Last study visit (week 26) | Defined as the time (or percentage of measurements) when the glucose value in the interstitial fluid is in the range of 3.9-7.8 mmol/L. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Coefficient of variation (CV) | Last study visit (week 26) | A measure of dynamic glucose variability. Calculated as a ratio of glucose concentration standard deviation and mean glucose concentration, expressed as a percentage. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). |
| Secondary | Mean Time in Range (TIR) | Study visit at week 13 and week 26 | Mean Time in Range (TIR) at study visit at week 13 and week 26. Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in % or in hours and minutes). |
| Secondary | Mean glucose concentration | Last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L). |
| Secondary | Proportion of participants with Coefficient of variation (CV) below or equal to 36% | Last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). |
| Secondary | Standard deviation of mean glucose concentration | Last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in mmol/L). |
| Secondary | Proportion of participants with Time in Range (TIR) above 70% | Last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). |
| Secondary | Proportion of participants with Time in Range (TIR) above 90% | Last study visit (week 26) | Assesment by Continuous Glucose Monitoring system FreeStyle Libre 2 (in %). |
| Secondary | Proportion of participants with Glycated hemoglobin (HbA1c) below 6.5% | Last study visit (week 26) | Assessment by biochemical methods (in %) |
| Secondary | Proportion of participants with Glycated hemoglobin (HbA1c) below 5.7% | Last study visit (week 26) | Assessment by biochemical methods (in %). |
| Secondary | Proportion of participants requiring rescue therapy with gliclazide | Baseline (week 0) to last study visit (week 26) | Measured in %. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06613854/registered