None listed
Conditions
Brief summary
Hybrid closed loop (HCL) systems for the treatment of type 1 diabetes are rapidly advancing, particularly with respect to the algorithms that are used to calculate the automated insulin delivery. Hybrid closed loop systems consists of an insulin pump, a continuous glucose monitor, and an algorithm that determines the rate of insulin delivery between meals. Meals are still required to be announced by the user, and an insulin bolus proportional to the carbohydrate ingested is delivered according to an individualised carbohydrate ratio. The first commercially available HCL system has been FDA approved and is available in the United States. However, ongoing enhancements are required to improve glycaemic outcomes and patient user experience. We will conduct a single-center pilot study, that is randomized, two arm parallel group in design in a hotel setting for 7 days, in subjects with type 1 diabetes on insulin pump therapy. Patients aged 13-25 years will be randomized in 2 groups to either use the 670G 3.0 system or the 670G 3.1+UmaxCB system. The objective is to assess function and usability of the two alternate algorithms in a highly supervised environment and provide an estimate of effect size and standard deviation in order to power future larger studies. During the study, we will challenge the performance of the two systems with different meal compositions and exercise.
Interventions
Random allocation to either the Minimed Medtronic 670G Version 3.0, or Minimed Medtronic 670G Version 3.1.hybrid closed loop systems.
The study will compare the MiniMedTM 670G insulin pump version 3.0, coupled with a 4th generation glucose sensor and GST3C transmitter, to the MiniMedTM 670G insulin pump v 3.1+ UmaxCB version. The insulin pump and glucose sensor are both external devices, that have a subcutaneous infusion site (the pump), or a sampling foil that is subcutaneously embedded as pa
Random allocation to either the Minimed Medtronic 670G Version 3.0, or Minimed Medtronic 670G Version 3.1.hybrid closed loop systems. The study will compare the MiniMedTM 670G insulin pump version 3.0, coupled with a 4th generation glucose sensor and GST3C transmitter, to the MiniMedTM 670G insulin pump v 3.1+ UmaxCB version. The insulin pump and glucose sensor are both external devices, that have a subcutaneous infusion site (the pump), or a sampling foil that is subcutaneously embedded as part of the sensor. Insulin pumps are worn anywhere on the body, with the infusion site inserted into subcutaneous tissue, usually the abdomen or buttocks. Glucose sensors are worn anywhere there is enough subcutaneous tissue, usually the abdomen or buttocks. The closed loop algorithm is contained in the MiniMedTM 670G series, using a modified proportional integrative derivative (PID) model, with insulin feedback and additional safety features. The algorithm receives (continuous glucose monitoring) CGM data every 5 minutes, and a “basal rate” insulin delivery is computed and adjusted every five minutes. Therefore, standard “basal” insulin that is pre-programmed in regular insulin pump therapy is replaced by the algorithm derived insulin delivery (given as a micro-bolus every 5 minutes). Meals will still be announced, and an insulin bolus delivered according to the individualised patient carbohydrate ratio and insulin sensitivity factor (should a correction bolus be required in addition to the insulin for carbohydrate). The differences between V3.0 and version 3.1 are that the version 3.1 can calculate an insulin bolus for hyperglycaemia correction, and has more tolerable parameters for staying in automode, All participants will have the intervention to manage their blood glucose levels for 7 days and nights, in a supervised outpatient environment (resort facility). Participants will not be restricted during the 7 days, and will just be observed. Participants are required to perform capillary glucose testing 4 -6 times a day, and supervising staff will perform 2 tests overnight. All test values will be used to calibrate the sensors. Participants will undergo two challenges to the hybrid system: unannounced lunch (i.e no insulin bolus given for the carb), and 60 minutes of moderate intensity exercise (jogging or cycling). The exercise challenge will occur after breakfast on day 6. The carbohydrate meal challenge will occur at lunch on day 6. Adherence is defined as time spent in automode and is an important outcome measure. There will be no efforts to improve fidelity, as this is designed to be real world experience assessment of the technology function.
Sponsors
princess Margaret Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 Diabetes duration > 1 year since diagnosis 2 Pump therapy for at least 6 months and Experience with sensor use 3. Age 13 - 25 4. 7.0% >A1C <10% at time of screening visit 5. willing to follow study instructions 6. Willing to perform at least 3 finger stick blood glucose measurements daily 7. willing to perform required sensor calibrations 8. Patient capable of reading and understand instructions in English
Exclusion criteria
1. Subject is unable to tolerate tape adhesive in the area of sensor placement 2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) 3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study drug or device in the last 2 weeks 4. Subject has a positive pregnancy screening test 5. Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception 6. Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit 7. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit 8. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit 9. Subject has a history of a seizure disorder 10. Subject has central nervous system or cardiac disorder resulting in syncope
Outcome results
None listed