Diabetes

Effects of continuous glucose monitoring versus blood glucose monitoring during a carbohydrate-restricted nutrition intervention in people with type 2 diabetes: 6-month follow-up outcomes from a randomized clinical trial

The IGNITE study (Impact of Glucose moNitoring and nutrItion on Time in rangE) was a randomized clinical trial that compared continuous glucose monitoring (CGM) and blood glucose monitoring (BGM) over six months in adults with type 2 diabetes following a medically supervised ketogenic diet program. The intervention included a very-low-carbohydrate diet and continuous remote care, with both groups receiving identical dietary guidance and clinical support. The aim was to determine whether CGM offered added benefits over BGM in glycemic control, medication use, weight loss, and related outcomes.

A total of 163 participants (mean age 53 years, mean HbA1c 8.1%) were randomized to either CGM or BGM. All participants tracked their glucose and blood ketone levels and were guided to maintain nutritional ketosis. The primary assessments took place at baseline and at 6 months, building on prior 3-month outcome data.

Results

• Time in range (70–180 mg/dL) increased from 61% to 87% in the CGM group and from 63% to 88% in the BGM group
• HbA1c dropped by 1.6 percentage points in the CGM group and 1.3 points in the BGM group
• Participants in both groups reduced their daily carbohydrate intake by over 120 grams and caloric intake by more than 600 kcal, with no significant differences between groups.
• Body weight decreased by approximately 22 lbs (10 kg) in the CGM group and 24 lbs (11 kg) in the BGM group.
• Over 70% of participants lost at least 5% of their baseline weight.
• Diabetes medication intensity, as measured by Medication Effect Score, declined in both groups, particularly due to reductions in sulfonylurea and SGLT2 inhibitor use.
• Diabetes distress scores improved similarly across both groups, with reductions in emotional, provider, and regimen distress components.

The findings indicate that both CGM and BGM are effective tools for supporting glycemic improvements and weight loss in the context of a carbohydrate-restricted diet and remote care. CGM did not provide additional benefit over BGM in this setting.