Clinical Evidence

 
 

The PROLOG Study

Basal-IQ™ Technology and Reduced Hypoglycemia

Clinical results from the PROLOG (PLGS for Reduction of Low Glucose) pivotal trial showed use of the system at home reduced time spent below 70 mg/dL by 31% compared to the control using a sensor-augmented t:slim X2™ Insulin Pump without automated insulin suspension.1 Importantly, this marked reduction of time spent in low glucose was accomplished without any increase in mean glucose and without rebound hyperglycemia. These results were seen in an already well-controlled population (baseline A1C = 7.3%).

t:slim X2 Insulin Pump with Basal-IQ Technology

 

 

Time < 70 mg/dL (%)

*P < 0.001

Time Below 70 mg/dL Graph

 

Time < 60 mg/dL (%)

*P < 0.001

Time Below 60 mg/dL Graph

 

Reduced

Basal-IQ Technology reduced time spent below 70 mg/dL.1

 

 

Time < 70 mg/dL at Baseline < 5%

n = 71  |  *P < 0.001

Time Below 70 mg/dL at Baseline Graph

 

Time < 70 mg/dL at Baseline > 5%

n = 30  |  *P < 0.001

Time Above 70 mg/dL at Baseline Graph

 

CGM

Subjects with more baseline hypoglycemia saw a greater effect.

 

 

Time in Range (%)

*P < 0.001

Time in Range Graph

 

Mean Glucose (mg/dL)

*P = 0.40

Mean Glucose Graph

 

Checkmark

Overall glycemic control improved while time < 70 mg/dL was minimized.

 

System Usability

Simple to teach. Simple to learn.

Results from a Human Factors study conducted to validate the safety of the Basal-IQ user interface demonstrated a 99% success rate among study participants who, after initial training, performed a series of critical tasks using the PLGS system. Out of 530 tasks performed, only seven task failures were observed (defined as needing assistance to complete), none of which were related to safety. The study included users age 6 and older (N = 53), with and without previous insulin pump and/or continuous glucose monitoring (CGM) experience.2

Additionally, most participants in the PROLOG pivotal study, many of whom had no previous experience with pumps or CGM systems, agreed or strongly agreed that the system was simple to learn and use.3

 

97%

of participants felt very confident using the system.1
 

93%

thought they would like to use the Basal-IQ system frequently.

91%

thought the Basal-IQ system was simple and easy to use.

90%

did not feel they had to learn a lot to get started with the system.

95%

did not need the support of a technical person to use the system.

 

 

Dexcom G6® CGM Technology

Exceptional Accuracy with zero fingersticks*

Dexcom CGM has been shown to reduce median time spent in hypoglycemia by 79% (< 60 mg/dL) at night. In separate clinical trials, Dexcom has demonstrated the sensor accuracy of their CGM technology in adult and pediatric use, with an overall MARD of 9% for adults and 10% for pediatrics (ages 2-17).‡ 4-5

Advantages of Dexcom G6 CGM

Known for exceptional accuracy and comfort, Dexcom is the #1-rated CGM brand.6 Benefits of the Dexcom G6 CGM System include:

  • Zero fingersticks*
  • 10-day sensor wear
  • Simple auto-applicator
  • Acetaminophen blocking§
  • View data on a smart device^
  • Share CGM data with up to 5 followers**

The t:slim X2 Insulin Pump with Basal-IQ Technology is the first and only automated insulin delivery system to integrate with this latest technology from Dexcom.

t:slim X2 Insulin Pump with Dexcom G6

 
 

 
 

Try out the new Basal-IQ feature with our free demo app.

Search for t:simulator™ wherever you purchase apps, or click the badges below to visit the download page.

AppBadge_AppleStore AppBadge_GooglePlay

*If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions.
†MARD is a statistical measure of accuracy accepted as the industry standard for CGM systems; the lower the number, the better.
‡Historical results based on Dexcom G5 CGM Systems.
§G6 readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000 mg every six hours. Taking a higher dose may affect the G6 readings.
^For a list of compatible devices, visit www.dexcom.com/compatibility. The Dexcom G6 CGM transmitter can only be paired with one medical device (either a Dexcom receiver or t:slim X2 Pump) and one consumer device (phone or tablet) at the same time.
**Separate Follow App required.

1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, 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 [In Press].
2. Dokken, et al. Usability of a Predictive Low Glucose Suspend (PLGS) Feature on a Touchscreen Insulin Pump. Poster presented at: 17th Annual Diabetes Technology Meeting; November 2-4, 2017; Bethesda, Maryland.
3. Pinsker, et al. Exceptional Usability of Tandem t:slim X2 Insulin Pump with Basal-IQ Predictive Low Glucose Suspend (PLGS): The PROLOG Study. Poster presented at: American Diabetes Association 78th Scientific Sessions; June 22-26, 2018; Orlando, FL.
4. Laffel L. Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Diabetes Technol Ther. 2016;18(S2). doi:10.1089/dia.2015.0380.
5. Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015;9(2):209-14. doi: 10.1177/1932296814559746.
6. dQ&A USA Diabetes Connections Surveys, 2013-2017.