Control-IQ Technology

In the International Diabetes Closed Loop Trial (IDCL), Protocol 3, time in range (70-180 mg/dL)* for participants using Control-IQ™ (CIQ) technology for six months was 71% per day compared to 59% when using sensor-augmented pump (SAP) therapy alone. During the overnight period, time in range was 76% compared to 59%.1

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Mean Time in Range (%)*
24-hour period • p<0.0001

Time in Range (24-hour period)

Overnight Mean Time in Range (%)*
12 am - 6 am • p<0.0001

Time in Range (24-hour period)

Basal-IQ Technology

The PLGS for Reduction of Low Glucose (PROLOG) Study, showed a 31% reduction in time spent below 70 mg/dL in participants who used the t:slim X2™ pump with Basal-IQ® technology compared to those using a sensor-augmented pump. This reduction occurred without rebound hyperglycemia.2

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Time Spent <70 mg/dL (%)
‡ p<0.001

Basal-IQ Time Spent <70 mg/dL

Time Spent <60 mg/dL (%)
‡ p<0.001

Basal-IQ Time Spent <60 mg/dL

Real-World Outcomes

Real-world use (n=2,712) of the t:slim X2 insulin pump with Basal-IQ technology demonstrated an even greater reduction in time spent in hypoglycemia compared to outcomes observed in the PLGS for Reduction of Low Glucose (PROLOG) Study (n=102).4

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Time Spent <70 mg/dL (%)

Basal-IQ Time Spent <70 mg/dL

Time Spent <60 mg/dL (%)

Basal-IQ Time Spent <70 mg/dL

Studies demonstrate the importance patients place on system usability

In the IDCL Trial, using a 5-point scale, Control-IQ participants rated the technology a 4.7 for ease of use, 4.6 for usefulness, and 4.5 for trust.1 In the PROLOG Study, 97% of participants indicated that they felt confident using the Basal-IQ system, and 97% indicated that the system was easy to use.3

Responsible Use of Control-IQ Technology

Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, patients are still responsible for actively managing their diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires that patients accurately input information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless all system components, including CGM, infusion sets and pump cartridges, are used as instructed. Importantly, the system cannot adjust insulin dosing if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be capable of identifying or addressing, patients should always pay attention to their symptoms and treat accordingly.

Responsible Use of Basal-IQ Technology

Systems like the t:slim X2 insulin pump with Basal-IQ technology are not substitutes for the active management of diabetes. There are common scenarios in which automated systems cannot prevent a hypoglycemic event. The Basal-IQ feature relies on current CGM sensor readings to function and will not be able to predict glucose levels and suspend insulin delivery if a patient’s CGM is not functioning properly or his/her pump is unable to receive the CGM signal. It’s recommended your patient always uses the components of the pump system (pump, cartridges, CGM, and infusion sets) according to the applicable instructions for use and checks them regularly to make sure they are functioning as expected. Patients should always pay attention to their symptoms, actively monitor and manage glucose levels, and treat according to your recommendations.

* As measured by CGM.
† Risk-adjusted difference (95% CI) for participant characteristics. All results are represented in mean values.

References:
1. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019;381(18):1707-17. DOI: 10.1056/NEJMoa1907863
2. Forlenza GP, Li Z, Buckingham BA, et al. Predictive low glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: Results of the PROLOG trial. Diabetes Care. 2018;41(10):2155-2161.
3. Brown S, et al. Clinical Acceptance of the Artificial Pancreas: The IDCL Trial. Poster presented at: American Diabetes Association 79th Scientific Sessions; June 9, 2019; San Francisco, CA.
4. Beck RW, et al. The association of biochemical hypoglycemia with the subsequent risk of a severe hypoglycemic event: analysis of the DCCT data set. Diabetes Technol Ther.

Important Safety Information

Caution: Federal (USA) law restricts the t:slim X2 insulin pump, the t:slim X2 pump with Basal-IQ technology, and Control-IQ technology to sale by or on the order of a physician. The t:slim X2 pump, the t:slim X2 pump with Basal-IQ technology, and Control-IQ technology are intended for single patient use. The t:slim X2 pump, the t:slim X2 pump with Basal-IQ technology, 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 integrated 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 pump is indicated for use in individuals 6 years of age and greater. t:slim X2 insulin pump with Basal-IQ technology: When used with a compatible integrated continuous glucose monitor (iCGM), the t:slim X2 insulin pump with Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings. The t:slim X2 pump with Basal-IQ technology is indicated for use in individuals 6 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 14 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

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 and the t:slim X2 pump with Basal-IQ technology are not indicated for use in pregnant women, people on dialysis, or critically ill patients. Users of the t:slim X2 pump, the t:slim X2 pump with Basal-IQ technology, and Control-IQ technology must: be able and willing to 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. For additional important safety information, visit www.tandemdiabetes.com/safetyinfo.