To evaluate the effect of Control-IQ® technology on time in range (TIR) and time above range (TAR) in people with type 1 diabetes (T1D) who were not meeting the TAR targets (i.e. <25% of sensor glucose time >180 mg/dL and <5% of sensor glucose time >250 mg/dL).
Sample included participants who were not meeting their TAR targets at Timepoint 1 (30 days pre-Control-IQ technology) and changes in their TIR and TAR outcomes at two subsequent timepoints along with patient-reported outcomes.
With continued use of Control-IQ technology, participants demonstrated significant glycemic improvements alongside increase in device satisfaction and reduction in diabetes impact.
Use of Control-IQ technology demonstrated clinically valuable improvements in hyperglycemia and TIR outcomes in T1D participants who did not previously meet guideline TAR targets.
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* Tandem Diabetes Care. † UC San Diego Design Lab Center for Health. ‡ Willes Consulting Group, Inc. § As measured by CGM. ^ p = <.0001 (p-value is from a Wilcoxon signed-rank test).
Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593-1603.
2. Marcovechhio ML. Complications of acute and chronic hyperglycemia. US Endocrinology. 2017;13(1):17–21.
3. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717.
Important Safety Information
RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin.
t:slim X2 insulin pump : The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The t:slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.
|WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.|
Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The t:slim X2 pump, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. Visit www.tandemdiabetes.com/safetyinfo for additional important safety information.