None listed
Conditions
Brief summary
This is a 6 month multi-centre randomized controlled trial assessing the effect of advanced hybrid closed loop (AHCL) in adolescents with poor glycaemic control and comparing this technology with their standard care. The purpose of this project is to utilize an automated insulin delivery system to improve glycaemic control which has been shown during in-home use by adolescents and adults with increased time in target, and reductions in HbA1c, hyperglycaemia and hypoglycaemia, compared to baseline. Hence, it would be valuable to test the effectiveness of AHCL in patients with poor glycaemic control. We hypothesize that AHCL system will circumvent the significant glycaemic excursion associated with conventional therapy in patients with poor glycaemic control. Reduced adherence to diabetes self-management tasks is often associated with poor glycaemic control and this trial will address, in effect, whether the challenge of managing AHCL is less than the challenge of routine treatment and will generate data that will inform approaches to enhance adherence.
Interventions
This is a prospective multicentre randomized controlled, two-arm unblinded, parallel study in free-living conditions, in adolescents with type 1 diabetes on insulin pump therapy.
Participants are randomized in two groups; either the control group (standard therapy) or the intervention group (hybrid closed loop, HCL). The control group will be participants on insulin pump therapy with or without continuous glucose monitoring (CGM).
Intervention arm: Medtronic Advanced HCL system for 6 months (8
This is a prospective multicentre randomized controlled, two-arm unblinded, parallel study in free-living conditions, in adolescents with type 1 diabetes on insulin pump therapy. Participants are randomized in two groups; either the control group (standard therapy) or the intervention group (hybrid closed loop, HCL). The control group will be participants on insulin pump therapy with or without continuous glucose monitoring (CGM). Intervention arm: Medtronic Advanced HCL system for 6 months (8 in-clinic visits in 6 months) OR Control arm: Standard care for 6 months (7 in-clinic visits in 6 months) This will be followed by an optional extension phase for another 6 months when those in the control arm would crossover to the intervention arm. In view of the recall on insulin pumps with clear retainer rings, the study will use the 780G insulin pump with the same algorithm, which has the added feature of bluetooth wireless communication with the compatible devices in the MiniMedTM 780G System connectivity. The MiniMedTM 780G Pump works with the following major components: 1) Continuous Glucose Monitoring (CGM) that includes the Guardian Link (3) Transmitter that is connected to the Guardian Sensor (3) to receive sensor glucose values at 5 minute intervals; 2) blood glucose meter (Roche Accu-Chek®) that will be used to calibrate the sensor and has the ability to send blood glucose values wirelessly as a convenience to the user; 3) MiniMedTM Clinical App to allow upload of data wirelessly, for sharing of glucose levels To maintain the same functionality as the 670G 4.0 pump for the trial, we will not be using the MinimedTM Clinical App.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago) 2. Fasting C peptide <0.1nmol/L (in the absence of hypoglycaemia) 3. Pump therapy for at least 6 months 4. Age 12 to 25 years 5. Recent HbA1c above 8.5% in the last 3 months 6. Mean HbA1c above 8.5% for 6 months 7. Willing to follow study instructions 8. Willing to perform at least 3 finger stick blood glucose measurements daily 9. Willing to perform required sensor calibrations 10. Capable of reading and understand instructions in English 11. Living in an area with internet and cellular phone coverage 12. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
Exclusion criteria
1. Severe DKA in the 6 months prior to the screening visit 2. Use of any non-insulin glucose-lowering agent within the past 3 months 3. Commenced CGM in the 3 months prior to the screening visit 4. Pregnancy or planned pregnancy within the study period 5. Uncontrolled coeliac disease (not following a gluten free diet), or other untreated malabsorption 6. Uncontrolled thyroid disease 7. Clinically-significant gastroparesis 8. Poor visual acuity precluding use of the investigational technology 9. Inability or unwillingness to meet protocol requirements
Outcome results
None listed