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
Princess Margaret Hospital for Children
100 participants
Nov 26, 2009
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
Inclusion Criteria4
- Duration of diabetes greater than or equal 12 months
- On insulin pump therapy greater than or equal to 6 months
- Glycated haemaglobin (HbA1C) between 6 and 8.5%
- Impaired awareness of hypoglycaemia
Exclusion Criteria4
- Has adrenal insufficiency
- Has growth hormone insufficiency
- Has multiple pituitary hormone deficiency
- Is pregnant
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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 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)
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ACTRN12610000024044