Trial results for a study investigating a novel continuous glucose monitor (CGM)-based titration algorithm for basal insulin in Type 2 Diabetes participants were posted on ClinicalTrials.gov on 2026-03-04, showing that the CGM-based approach led to a mean increase of 20.3 percentage points in Time in Range (3.9-10.0 mmol/L) compared to 8.3 percentage points with standard self-monitoring blood glucose (SMBG) titration.
Background
Type 2 Diabetes is a chronic metabolic condition characterized by high blood sugar levels, often managed with lifestyle changes, oral medications, and injectable therapies, including basal insulin. Basal insulin therapy is crucial for many patients to achieve glycemic targets, but its effective titration often relies on frequent self-monitoring of blood glucose (SMBG). While SMBG provides intermittent glucose readings, continuous glucose monitoring (CGM) offers real-time, continuous data, potentially allowing for more precise and proactive insulin adjustments. Improving glycemic control, particularly by increasing Time in Range (TIR) and reducing HbA1c, is vital for preventing long-term complications associated with Type 2 Diabetes.
Trial design
This completed study, identified as Phase NA, enrolled 30 participants with Type 2 Diabetes who were already using long-acting insulin. The trial's goal was to compare the effect of a CGM-based titration algorithm to standard titration guided by SMBG. Participants were followed for 18 weeks and provided with Degludec insulin, an insulin pen, and a Dexcom G6 CGM. The study aimed to assess differences in glycemic control between the two titration strategies.
Key results
The trial results demonstrated notable differences in glycemic control parameters between the two titration methods:
- For Change in Time in Range 3.9-10.0 mmol/L (70-180 mg/dL), the Continuous Glucose Monitoring (CGM) Based Titration group showed a mean increase of 20.3 percentage points (Standard Deviation: 18.1), while the Standard Self-Monitoring Blood Glucose (SMBG) Titration group showed a mean increase of 8.3 percentage points (Standard Deviation: 20.0).
- Regarding Change in HbA1c, the CGM Based Titration group experienced a mean reduction of -0.74 percentage (Standard Deviation: 0.60), compared to a mean reduction of -0.28 percentage (Standard Deviation: 1.16) in the SMBG Titration group.
- For Change in Time in Tight Range 3.9-7.8 mmol/L (70-140 mg/dL), the CGM Based Titration group saw a mean increase of 21.2 percentage points (Standard Deviation: 17.4), versus a mean increase of 5.3 percentage points (Standard Deviation: 14.4) in the SMBG Titration group.
- The Change in Time Above 10.0 mmol/L (180 mg/dL) was a mean decrease of -20.2 percentage points (Standard Deviation: 18.3) for the CGM Based Titration group, and a mean decrease of -7.9 percentage points (Standard Deviation: 20.9) for the SMBG Titration group.
- For Change in Time Above 13.9 mmol/L (250 mg/dL), the CGM Based Titration group showed a mean decrease of -8.9 percentage points (Standard Deviation: 14.6), while the SMBG Titration group had a mean decrease of -4.0 percentage points (Standard Deviation: 15.6).
- The Change in Mean Glucose Level was a mean decrease of -30.3 mg/dL (Standard Deviation: 30.4) for the CGM Based Titration group, compared to a mean decrease of -8.2 mg/dL (Standard Deviation: 38.5) for the SMBG Titration group.
A Mixed Models Analysis indicated a mean difference (Final Values) of 14.6 with a p-value of 0.001, and a 5.0% confidence interval lower bound of 4.0, further supporting the observed differences.
What this means
The results suggest that a CGM-based titration algorithm for basal insulin significantly improves glycemic control in patients with Type 2 Diabetes compared to standard SMBG-guided titration. The substantial increases in Time in Range and Time in Tight Range, alongside reductions in HbA1c and time spent in hyperglycemia, indicate a more effective and precise approach to insulin management. For patients, this could translate to better overall health outcomes, reduced risk of diabetes-related complications, and potentially a more streamlined and less burdensome self-management routine. The findings support the integration of CGM technology into insulin titration protocols for Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06111508, titled "The Effect and Safety of a Novel CGM-Based Titration Algorithm for Basal Insulin in T2DM Participants.", were posted on 2026-03-04 on clinicaltrials.gov.