Trial results for a study investigating continuous glucose monitor (CGM) initiation approaches in Type 2 Diabetes patients were posted on ClinicalTrials.gov on 2026-03-04, showing that a nutrition-focused approach improved Time in Range (TIR) by 25%.
Background
Type 2 Diabetes is a chronic condition characterized by high blood glucose levels. Continuous Glucose Monitoring (CGM) systems are increasingly utilized to help individuals manage their glucose levels by providing real-time data. The effectiveness of CGM use can be influenced by how it is introduced and integrated into a patient's self-management routine. This study explored whether a structured, nutrition-focused approach to CGM initiation could lead to better glucose control outcomes, such as increased Time in Range (TIR), compared to a self-directed approach. Time in Range is defined as the percentage of time a person's glucose is between 70 and 180 mg/dL.
Trial design
This completed study, identified as Phase NA, enrolled 159 participants with Type 2 Diabetes. The trial included two phases, with Phase 1 focused on understanding the difference between two ways of introducing a continuous glucose monitor (CGM) to people with Type 2 Diabetes. The study evaluated the effect of a nutrition-focused approach (NFA) versus a self-directed approach (SDA) during CGM initiation on time in range (TIR) glucose and other related outcomes.
Key results
The trial results for Phase 1 showed notable differences between the two CGM initiation approaches:
- For Phase 1 Change in CGM-derived Time in Range (TIR), the Nutrition Focused Approach (NFA) group demonstrated a mean change of 25% of time in 24 hours, compared to the Self Directed Approach (SDA) group which showed a mean change of 16% of time in 24 hours.
- Regarding Change in CGM Derived % Time Above >180 mg/dL, the NFA group saw a mean reduction of -25% time in 24 hours, while the SDA group had a mean reduction of -16% time in 24 hours.
- For Change in CGM-derived % Time Above >250 mg/dL, the NFA group experienced a mean reduction of -14% time in 24 hours, versus a mean reduction of -6% time in 24 hours for the SDA group.
- The Change in CGM-derived % Time in Tight Range (% Time With Glucose 70-140 mg/dL) was a mean increase of 18% time in 24 hours for the NFA group, compared to 12% time in 24 hours for the SDA group.
- The Total Healthy Eating Index (HEI) Score was a mean of 65 units on a scale for the NFA group and 63 units on a scale for the SDA group.
- For Change in CGM-derived % Time Below <70 mg/dL, the NFA group showed a mean change of 0.1% time in 24 hours, while the SDA group showed a mean change of -0.23% time in 24 hours.
What this means
The results suggest that a nutrition-focused approach to continuous glucose monitor (CGM) initiation can significantly improve glucose management for individuals with Type 2 Diabetes. The consistently better outcomes observed in the nutrition-focused group across several key metrics, particularly the greater increase in Time in Range and reduction in time spent in hyperglycemic states, indicate that structured guidance alongside CGM use may be more effective than a self-directed approach. These findings highlight the potential benefits of integrating nutritional education and support when introducing CGM technology to patients, offering a pathway to enhanced glycemic control and potentially better long-term health outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05928572, titled "My Diabetes Study - CGM Initiation Approach & Time In Range", were posted on 2026-03-04 on clinicaltrials.gov.