RecruitingPhase 4ACTRN12610000024044

The Low Glucose Suspend Trial - Comparing insulin pump therapy with low glucose suspend feature versus standard insulin pump therapy in patients with type 1 diabetes with hypoglycaemia unawareness

The use of continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and low glucose suspend feature (CSII + RT-CGMS + LGS) versus continuous subcutaneous insulin infusion only (CSII) in patients with type 1 diabetes (T1D) with impaired awareness of hypoglycaemia - a randomised controlled trial


Sponsor

Princess Margaret Hospital for Children

Enrollment

100 participants

Start Date

Nov 26, 2009

Study Type

Interventional

Conditions

Summary

This study will compare the new insulin pump with low glucose suspend feature with current pump therapy to see if there is any change in rates of hypoglycaemia.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing a newer insulin pump that automatically stops delivering insulin when blood sugar drops too low (called a 'low glucose suspend' feature) to a standard insulin pump in people with type 1 diabetes who have trouble sensing when their blood sugar is low. When people lose the ability to feel low blood sugar (a condition called hypoglycaemia unawareness), the automatic shut-off feature may prevent dangerous low blood sugar episodes. You may be eligible if: - You are between 4 and 50 years old - You have had diabetes for at least 12 months - You have been using an insulin pump for at least 6 months - Your HbA1c (average blood sugar measure) is between 6% and 8.5% - You have impaired awareness of low blood sugar (hypoglycaemia unawareness) You may NOT be eligible if: - You have adrenal insufficiency - You have growth hormone deficiency - You have multiple pituitary hormone deficiencies - You are pregnant Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention involves continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and low glucose suspend feature (Paradigm Veo)for six months duration. Dose of i

The intervention involves continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and low glucose suspend feature (Paradigm Veo)for six months duration. Dose of insulin will remain unchanged as per clinician prescribed regimen. Continuous glucose monitoring will involve insertion of a sensor just under the skin that sends continuous blood glucose readings back to the Paradigm Veo pump. This pump has the added feature of Low Glucose Suspend function. If a low glucose level is detected and the patient does not respond to the alarm, the pump will suspend insulin infusion for 2 hours. Both the pump and glucose sensor system will be worn for the entire 6 months.


Locations(1)

Australia

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ACTRN12610000024044