None listed
Conditions
Brief summary
The research team have developed a novel artificial pancreas algorithm named SCENIC. The SCENIC algorithm has been shown to control insulin delivery and maintain good glycaemic control, including following exercise and food, on a diabetes simulator. In order to advance this technology, the next stage is to test the algorithm in people with type 1 diabetes. Therefore, this study aims to compare the SCENIC algorithm with standard insulin. Adults and children with type 1 diabetes will be given a meal and either standard insulin or SCENIC controlled insulin and the blood glucose will be monitored for 4 hours after the meal. To achieve this aim, we will recruit 10 children and adults with type 1 diabetes using insulin pump therapy (a small, programmable device that gives insulin). Participants will attend HMRI on 5 consecutive evenings, during which they will be given a test meal with the insulin dose determined using either standard clinical practice or the SCENIC algorithm. Their blood glucose levels will be monitored for 4 hours following the meal to determine whether the SCENIC algorithm can improve their blood glucose control without causing hypoglycaemia.
Interventions
The Hunter New England Diabetes Research Network (HNEHRN) has developed a novel artificial pancreas algorithm with multiple future food and exercise scenarios called scenario based moving horizon stochastic dynamic programming (SCENIC). SCENIC will allow the integration of multiple inputs, learnt responses and patterning data so the system can cope with events such as food and exercise without hypoglycaemia. This study will determine if SCENIC is capable of maintaining glycaemic control during a meal. Participants will attend the Hunter Medical Research Institute for 5 consecutive evenings at 4pm, having fasted and not adjusted their insulin since 1pm. Participants will have their blood glucose levels monitored using capillary blood sampling and a glucometer at 15 min intervals from 4-5pm. At 5pm, participants will be given the standardised test meal and their blood glucose levels will continue to be monitored at 15 min intervals until 9pm. On the first night, no mealtime insulin dose will be administered. On the second night, the usual mealtime insulin bolus will be administered according the the participant's usual clinical care. On nights 3-5, the insulin dose will be determined using SCENIC. In the event of hypoglycaemia prior to the session, the session will be rescheduled. In the event of hypoglycaemia during a session, the session will be terminated and the participant treated according to their routine clinical care.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Type 1 diabetes mellitus for over 1 year 2. HbA1c less than or equal to 69 mmol/mol (8.5%) 3. Age 12y to 45yo 4. Body mass index less than or equal to 97th percentile 5. No other medical conditions 6. No diabetes complications
Exclusion criteria
1. Unwilling/unable to comply with study protocol 2. HbA1c > 69 mmol/mol (> 8.5%) 3. Any medical condition other than type 1 diabetes 4. Diabetes complications including gastroparesis 5. Medications that would alter glycaemic response