Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
NCT07919236, Not applicable, Recruiting, Medical University of Bialystok
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin | ClinicalTrials.gov |
| NCT number | NCT07919236 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Medical University of Bialystok | ClinicalTrials.gov |
| Conditions | Type 2 Diabetes | ClinicalTrials.gov |
| Interventions | Continuous glucose monitoring, Self-monitoring of blood glucose | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in time in range | Week 12 | Observed change in time in range (70-180 mg/dl) from baseline to week 12 in the group using CGM system compared to the group using SMBG. | ClinicalTrials.gov |
| Secondary | Change in HbA1c | Week 12 | Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in TITR | Week 12 | Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in TAR | Week 12 | Observed change in time above range (TAR; \>180 mg/dl) from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in TBR | Week 12 | Observed change in time below range (TBR; \<70 mg/dl) from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in CV | Week 12 | Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in body weight (kg) | Week 12 | Observed change in body weight from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in markers of early vascular disease | Week 12 | Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from baseline to week 12. | ClinicalTrials.gov |
| Secondary | Change in diabetes distress: DDS | Week 12 | Observed change in diabetes distress measured with DDS questionnaire from baseline to week 12. DDS is a 17-item questionnaire assessing diabetes distress over the previous month. Scores \<2 points indicates no/little distress, 2-2.9 points - moderate distress, and ≥3 points - high distress. | ClinicalTrials.gov |
| Secondary | Change in PHQ-9 | Week 12 | Observed change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 12. PHQ-9 is a 9-item questionnaire for screening, diagnosing, monitoring and measuring the severity of depression. Total score: 0-27 points; higher scores reflect greater severity of depressive symptoms. | ClinicalTrials.gov |
| Secondary | Change in quality of life: WHOQOL-BREF questionnaire | Week 12 | Observed change in abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire from baseline to week 12. Total score: 0-100 points; higher scores reflect higher quality of life. | ClinicalTrials.gov |
| Secondary | Change in sleep quality: PSQI | Week 12 | Observed change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI) from baseline to week 12. Total score: 0-21 points; a score greater than 5 indicates significant sleep difficulties. | ClinicalTrials.gov |
| Secondary | Change in TIR after completing the intervention | Week 24 | Observed change in time in range (TIR; 70-180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in HbA1c after completing the intervention | Week 24 | Observed change in the percentage of glycated haemoglobin (HbA1c) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in TITR after completing the intervention | Week 24 | Observed change in time in tight range (TITR; 70-140 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in TAR after completing the intervention | Week 24 | Observed change in time above range (TAR; \>180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in TBR after completing the intervention | Week 24 | Observed change in time below range (TBR; \<70 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in CV after completing the intervention | Week 24 | Observed change in glycaemic variability assessed with coefficient of variation (CV) from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
| Secondary | Change in markers of early vascular disease after completing the intervention | Week 24 | Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from week 12 (end of intervention) to week 24 (post-intervention follow-up). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)