Trial results investigating the use of continuous glucose monitoring (CGM) in hospitalized patients with Type 1 and high-risk Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-10-15. The intervention group for Type 2 Diabetes demonstrated an observed improvement in time in range, with one analysis showing a mean difference of 11.257 with a p-value of 0.0404.
Background
Managing blood glucose levels effectively in hospitalized patients with diabetes is crucial for patient safety and recovery. Uncontrolled glucose can lead to complications, prolonged hospital stays, and adverse outcomes. Traditional intermittent blood glucose monitoring may not capture the full picture of glycemic variability. The use of continuous glucose monitoring (CGM) devices offers real-time tracking of glucose parameters, similar to other vital signs, allowing healthcare teams to make timely adjustments to treatment plans and potentially improve patient care and safety during hospitalization.
Trial design
This completed study enrolled 157 participants to investigate the management of Type 1 and high-risk Type 2 Diabetes in a hospital setting. The conditions studied were Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2. The program utilized wireless continuous glucose monitoring devices (CGM) to track patients' glucose parameters in real-time. A team of health professionals monitored the patients' progress, communicated recommendations, and was available for discussion when recommended targets were not achieved. Health teams used sensor results alongside existing electronic medical records data to evaluate progress and manage care. The study included an Intervention group and a Control group for Type 2 Diabetes, as well as an Observational T1D group.
Key results
The study collected several key measurements related to blood glucose time in range and hypoglycemia:
- Type 2 Diabetes Blood Glucose Time in Range (70-180 mg/dL)
- In the Intervention group, the median was 25.31 percentage of time during CGM use.
- In the Control group, the median was 19.89 percentage of time during CGM use.
- In the Observational T1D group, the median was 26.04 percentage of time during CGM use.
- Type 2 Diabetes Blood Glucose Time in Range (70-200 mg/dL)
- In the Intervention group, the median was 42.82 percentage of time during CGM use.
- In the Control group, the median was 33.38 percentage of time during CGM use.
- In the Observational T1D group, the median was 33.57 percentage of time during CGM use.
- Type 2 Diabetes Blood Glucose Time in Range (70-250 mg/dL)
- In the Intervention group, the median was 72.83 percentage of time during CGM use.
- In the Control group, the median was 63.95 percentage of time during CGM use.
- In the Observational T1D group, the median was 65.97 percentage of time during CGM use.
- Percentage Time in Hypoglycemia (<70 mg/dL)
- In the Intervention group, the median was 0 percentage of time during CGM use.
- In the Control group, the median was 0 percentage of time during CGM use.
- In the Observational T1D group, the median was 0 percentage of time during CGM use.
Key analyses from the trial included:
- A linear regression analysis reported a p-value of 0.146.
- Another linear regression analysis reported a p-value of 0.05.
- A linear regression analysis reported a mean difference (Net) of 6.338 with a p-value of 0.05.
- A linear regression analysis reported a mean difference (Net) of 9.141 with a p-value of 0.0615.
- A linear regression analysis reported a mean difference (Net) of 11.257 with a p-value of 0.0404.
- A linear regression analysis reported a mean difference (Net) of 0.155 with a p-value of 0.268.
What this means
The results suggest that continuous glucose monitoring, coupled with a dedicated monitoring team, may improve glycemic control in hospitalized patients with Type 2 Diabetes. The intervention group consistently showed higher median percentages for time in range across all measured glucose targets (70-180 mg/dL, 70-200 mg/dL, and 70-250 mg/dL) compared to the control group. Notably, the median time in range for 70-250 mg/dL was 72.83 percent in the intervention group versus 63.95 percent in the control group. One statistical analysis indicated a significant mean difference of 11.257 with a p-value of 0.0404. Additionally, all groups, including the intervention and control, reported a median of 0 percent time in hypoglycemia (<70 mg/dL), indicating that the intervention did not increase the risk of low blood sugar. These findings highlight the potential benefits of real-time glucose monitoring and proactive management in enhancing inpatient diabetes care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03068273, titled "Managing Type 1 and High Risk Type 2 Diabetes in the Hospital Setting: Glucose as a Vital Sign", were posted on 2025-10-15 on clinicaltrials.gov.