Trial results for a study investigating glucagon response and glycaemic control in Type 1 Diabetes were posted on ClinicalTrials.gov on 2025-12-17, involving 24 participants. The study found a significant improvement in time spent within the target glycaemic range for participants using automated insulin delivery and a low carbohydrate diet.
Background
Almost all individuals with Type 1 Diabetes for five years or more develop a defect in glucagon secretion. Glucagon is a crucial hormone involved in the body's response to low blood glucose (hypoglycemia) by releasing glucose stores from the liver. This defect increases the risk of severe hypoglycemia. The underlying reason for this glucagon deficiency in people with Type 1 Diabetes is not fully understood. This study aimed to examine the glucagon response to hypoglycemia in Type 1 Diabetes patients and assess whether tight blood glucose control could restore this response.
Trial design
This completed study, designated as Phase NA, enrolled 24 participants with conditions including Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia, Hypoglycemia, Hypoglycemia Unawareness, and Glucagon Deficiency. The trial compared two groups: Group 1 - Standard Care and Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet, to investigate their effects on glucagon response and glycaemic control.
Key results
The trial reported several key measurements:
- The Change in Plasma Glucagon Levels (Pmol/L) Measured During Normoglycaemic and Hypoglycaemia:
- For Group 1 - Standard Care, the median was 1.34 pmol/L.
- For Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet, the median was 1.68 pmol/L.
- Another measurement for Group 1 - Standard Care showed a median of 2.26 pmol/L.
- Another measurement for Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet showed a median of 0.31 pmol/L.
- Statistical analysis (Wilcoxon (Mann-Whitney)) for these measurements showed p-values of 0.99 and 0.64, indicating no significant difference between groups for these specific glucagon level changes.
- Time in Glycaemic Range (3.9-10mmol/L):
- For Group 1 - Standard Care, the mean was 51.46% (Standard Deviation 13.63).
- For Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet, the mean was 53.55% (Standard Deviation 14.48).
- Another measurement for Group 1 - Standard Care showed a mean of 44.26% (Standard Deviation 11.5).
- Another measurement for Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet showed a mean of 78.01% (Standard Deviation 6.32).
- A third measurement for Group 1 - Standard Care showed a mean of 39.64% (Standard Deviation 20.15).
- A third measurement for Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet showed a mean of 76.85% (Standard Deviation 9.61).
- Statistical analysis (ANOVA) for these measurements showed p-values of 0.37, 0.0001, and 0.2. The p-value of 0.0001 indicates a statistically significant improvement in Time in Glycaemic Range for the Automated Insulin Delivery and Low Carbohydrate Diet group compared to standard care for one of the measurements.
- Time Spent Below the Target Glycaemic Range (<3.9mmol/L):
- For Group 1 - Standard Care, the mean was 1.02% (Standard Deviation 0.62).
- For Group 2 - Automated Insulin Delivery and Low Carbohydrate Diet, the mean was 2.13% (Standard Deviation 3.17).
- Statistical analysis (ANOVA) showed a p-value of 0.95, indicating no significant difference between groups for time spent below the target glycaemic range.
What this means
The results suggest that while the intervention of Automated Insulin Delivery and a Low Carbohydrate Diet did not significantly alter plasma glucagon levels or time spent below the target glycaemic range, it led to a significant improvement in the time participants spent within the desired glycaemic range (3.9-10mmol/L). This finding indicates a potential benefit of this combined approach for improving overall blood glucose control in individuals with Type 1 Diabetes, which could have practical implications for daily management and reducing the burden of hyperglycemia.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04614168, titled "Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes", were posted on 2025-12-17 on clinicaltrials.gov.