None listed
Conditions
Brief 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.
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
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.
Sponsors
Princess Margaret Hospital for Children
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
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 criteria
Has adrenal insufficiency Has growth hormone insufficiency Has multiple pituitary hormone deficiency Is pregnant
Outcome results
None listed