This trial is examining the effectiveness and safety of single-hormone closed-loop (SHCL) compared with sensor-augmented pump therapy (SAPT) in controlling glucose levels in patients with type 1 diabetes (T1D). The main outcome to be measured will be the percentage of time that glucose levels are between 3.9 and 10 mmol/L.
This study is being conducted in Canada, Quebec.
The details
A treatment option for patients with T1D is with SAPT. This device detects the level of glucose in the body and gives insulin injections via a pump every 5 mins based on the glucose reading. Unfortunately, this treatment option may not always keep the glucose levels in the normal range. An alternative is to use the SHCL. This device detects glucose levels in the blood, which are sent to a smartphone which then calculates the correct dose of insulin to the pump to be injected. It is not known if SHCL is more effective and safe at treating T1D.
This study is being done to investigate the effectiveness and safety of SHCL compared with SAPT in regulating glucose levels in patients with T1D. The main outcome to be measured will be the percentage of time that glucose levels are between 3.9 and 10 mmol/L after a 12 day follow up.
Who are they looking for?
36 participants with T1D will be recruited. Patients must have a diagnosis of T1D for at least 1 year and have been on an insulin pump for at least 3 months. Their HbA1c must be of 12% or lower.
Patients cannot participate if they have severe kidney, nerve or eye damage as a result of diabetes. They must not have had a recent heart attack, heart surgery or be on warfarin (a blood thinner) therapy long term. Women may not take part if are pregnant or breastfeeding. Participants must not have had a severe low glucose or high glucose episode in the last 3 months, are allergic to the drugs or have another serious medical illness.
How will it work
There will be two groups. Group 1 will receive SAPT for 12 days. Group 2 will receive SHCL therapy for 12 days. Blood glucose levels will be closely monitored.
