Adverse events such as severe hypoglycaemia and diabetic ketoacidosis (DKA) rates were lower for users of t:slim X2 with Control-IQ technology compared to historical data for both adults and children. On average, adult participants achieved >70% CGM time in range, while paediatric participants achieved >60% CGM time in range, achieving international consensus guidelines. Patient reported outcomes indicate a positive effect of t:slim X2 with Control-IQ technology on the burden of diabetes.
The use of Control-IQ technology is effective in lowering HbA1c and improving Time in Range (TIR) without increasing TBR in adults with poorly controlled T1D with missing meal boluses. People who rarley bolus (>90% Auto Corrections) showed a 15% increase in TIR and a 1.5% drop in HbA1c. Therefore, patients with higher HbA1c with missing meal boluses should not be excluded from clinical trials or offering hybrid closed loop (HCL) therapy in clinical practice.
Using Control-IQ technology, the user-initiated correction boluses decreased from 2.7 to 1.8 per day, while user-initiated meal boluses remained stable at 3.6 to 3.8 per day. People with the highest GMI, >8.0, showed the greatest improvement in Time in Range (TIR), with no increase in hypoglycaemia. It is thought that this is due to the auto correction function of Control-IQ technology.
Children on Control-IQ technology compared to sensor augmented pump achieved 11% more Time in Range (TIR) which is equivalent to 2.6 hours per day (aged 6 -13 years).
Patients on Control-IQ technology average 2.6 more hours per day spent in the target range than those not on a Hybrid Closed Loop (HCL) system. This was evident immediately and remained consistent over 6 months. Sleep Activity enables 90% of users to have levels within range between the hours of 4 – 7 am.
People using Control-IQ technology reported outcomes reflecting high device satisfaction and reduced diabetes impact. Factors contributing to high trust in the system included sensor accuracy, improved diabetes control, reduction in extreme blood glucose levels, and improved sleep quality. In addition, participants reported improved quality of life, ease of use, and efficient connectivity to the continuous glucose monitoring system as being valuable features of the system.
67% of people using Control-IQ technology have less aggressive settings than the AACE guidelines (100/TDI). The Correction Factor is a unique parameter with Control-IQ technology, that affects user boluses, the AutoBolus, and the intensity of basal modulation. For Control-IQ technology users, strengthening the Correction Factor may improve Time in Range (TIR) without necessarily impacting hypoglycaemia. Both C:I ratio and basal rate changes can be considered as well, although may predict more hypoglycaemia.
People who used Control-IQ technology improved their Time in Range (TIR) and also had significant reductions in mean glucose, hyperglycaemia metrics, hypoglycaemic metrics, and HbA1c. At baseline, the amount of hypoglycaemia was low, but a reduction in time <3.9mmol/L and time <3.1mmol/L were observed with Control-IQ technology.
Control-IQ technology use increased Time in Range (TIR) from 63.6% to 73.6%, which is equivalent to 2.4 hours per day, seen across all age groups. These results were evident after the first two weeks and was sustained throughout the entire year. A notable improvement was also seen overnight, with a median time in range exceeding 90% between 04:00 and 07:00, demonstrating the effectiveness of the Sleep Activity feature in Control-IQ technology. Time below Range (TBR) remained consistent at ∼1%.
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