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New Study Demonstrates Glucose RapidSpray Device Rapidly Alleviates Major Symptom of Type 1 Diabetes in Children

Sep 23, 2008

A study sponsored by Toronto, based Generex Biotechnology suggests that a novel glucose-delivering device, Glucose RapidSpray™, provides a higher degree of glycemic control in children with type 1 diabetes, as well as greater compliance. Hypoglycemia, a low blood sugar condition common in people with diabetes, occurs when doses of insulin or oral medications are not balanced properly by food ingestion. Sometimes known as “insulin reaction,” hypoglycemia can occur in both type 1 and type 2 diabetics, including those who are not insulin-dependent.

On the surface, hypoglycemia is “easy” to treat since patients need only consume an appropriate dose of glucose to counteract their low blood sugar. In practice, however, the condition is difficult to treat, particularly in children younger than five years of age, because of difficulties in administering the correct glucose dose as well as patient compliance. Some children with hypoglycemia have difficulty swallowing, which makes administration of oral glucose agents problematic. Another factor is the child’s body weight, typically quite low, which requires small, precise glucose dosages. Also of concern is the potential for hyperglycemic (high blood sugar) rebound, caused by too-high dosing and a counter-regulatory hormone response.

The study involved administration of precise doses of glucose through the Glucose RapidSpray™ (GRS) device, developed by Generex Biotechnology, during the first signs of hypoglycemia in children with type 1 diabetes. The goal of the study was to improved metabolic control as measured by A1c over a six-month follow up period. The Glucose RapidSpray configuration during the study consisted of a 10-milliliter bottle containing ten grams of glucose solution plus artificial flavors and an excipient to facilitate buccal absorption of glucose. The device works by delivering a fine spray containing glucose in quantities as small as half a gram.

The study randomized twenty-seven children with type 1 diabetes into two groups. One group received Glucose RapidSpray on an as-needed basis depending on hypoglycemic symptoms. The control group treated hypoglycemia using traditional methods that include sugar pills, fruit juice, and candies.

Investigators noted HbA1c, number and types of hypoglycemic episodes, compliance, and quality of life in the test subjects at the beginning of the study, at three months, and at the end of the study (six months).

The groups were similar in characteristics at the beginning of the study. At three months both groups showed a significant improvement in HbA1c, but improvement was similar between groups.

However, at six months there was a statistically significant difference in the improvement of the A1c in the Glucose RapidSpray-treated group compared with the control group (0.98% vs. 0.60% difference, respectively, p<0.02). Those receiving treatment through Glucose RapidSpray also had a tendency towards for fewer hypoglycemic episodes during the day (p=0.09). Children appeared to comply with GRS treatment more readily, and parents felt more comfortable managing hypoglycemic episodes using the device compared with conventional sources of glucose.

Presented at the 44th annual meeting of the European Association for the Study of Diabetes (EASD). The abstract, entitled, “Glucose RapidSpray™ for a New Management of Hypoglycemia in Children up to 5 Years of Age with Type 1 Diabetes.”


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