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

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 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