Tandem Diabetes Care Announces Publication of PROLOG Study Results in Diabetes Care Journal
Study Demonstrates Significant Reduction in Hypoglycemia without Rebound Hyperglycemia
“The results seen in the PROLOG study demonstrate that an automated
insulin delivery system can have a significant impact on glycemic
control without being overly complicated or burdensome for the patient,”
Basal-IQ Technology uses CGM readings to predict glucose levels 30 minutes ahead. If the glucose level is predicted to be less than 80 mg/dL, or if a CGM reading falls below 70 mg/dL, insulin delivery is suspended. Insulin delivery resumes as soon as sensor glucose values begin to rise.
“Subjects in the PROLOG study adopted the Basal-IQ system quickly and
easily. There was also no evidence of alarm fatigue, since alerts
related to insulin suspension and resumption are optional, allowing the
feature to operate quietly in the background,” said Dr.
Results from this study supported a regulatory filing for the t:slim X2
Pump with Basal-IQ Technology to the
Summary of Data Published in Diabetes Care1
Reductions in hypoglycemia – Use of the t:slim X2 Pump with Basal-IQ Technology in the PROLOG study reduced the number of sensor glucose readings below 70 mg/dL by 31 percent compared to the control period without automated insulin suspension. The reduction of time spent in low glucose was accomplished without any increase in the rate of hyperglycemia. Participants with higher hypoglycemia entering the study saw the largest improvement. A significant hypoglycemia reduction was seen with Basal-IQ Technology in all groups, irrespective of age, baseline HbA1c, or baseline hypoglycemia rates.
Usability – The t:slim X2 Pump with Basal-IQ Technology scored very high on the System Usability Scale survey, a standardized 10-item questionnaire that measures the perceived usability of a system, often used to evaluate non-medical consumer electronics. 93 percent of participants thought the system was easy to use, and 97 percent indicated they felt confident using the system.
Study adherence – Overall study adherence was high, with 99 percent of those enrolled completing the trial, and with the system active for 95 percent of the time during the Basal-IQ period. Median CGM use during the study periods was 95 percent when using Basal-IQ and 94 percent when using the pump without automated insulin suspension.
Insulin suspensions and insulin use – The mean suspension duration was 18 minutes per event, with a mean pump suspension time of 104 minutes per day. Mean daily bolus insulin amounts were identical between study phases. The basal insulin dose was reduced by approximately four percent in the Basal-IQ phase compared with the control period without automated insulin suspension. Mean basal insulin delivery was 1.2 units per day lower when using the Basal-IQ feature (P < 0.001).
Safety/adverse events – No severe hypoglycemic events were observed in the Basal-IQ phase of the study. There was one severe hypoglycemic event in the study phase without automated insulin suspension. There was no significant difference in the appearance of ketones between the two treatment phases.
The PROLOG study was a multi-center, randomized, crossover clinical
trial comparing two three-week periods of at-home insulin pump use, one
period using the t:slim X2 Pump with Basal-IQ Technology, and another
period using a CGM-integrated t:slim X2 Pump without automated insulin
suspension. The study included 102 participants with type 1 diabetes
ages 6 to 72 at four research centers across
t:slim X2 Insulin Pump with Basal-IQ Technology Coming Soon
The t:slim X2 Insulin Pump with Basal-IQ Technology can be ordered today
and is anticipated to begin shipping in
Free Software Update for Current t:slim X2 Pump Users
All in-warranty t:slim X2 Pump users in
Free Basal-IQ Technology Demo App
Tandem’s free t:simulator™ App lets users experience the touchscreen interface of the t:slim X2 Insulin Pump with Basal-IQ Technology directly on a mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.
Forward Looking Statement
This press release contains “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the anticipated launch of the t:slim X2
Insulin Pump with Basal-IQ Technology in
* If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. Dexcom G6 CGM sold separately. Separate Follow App required.
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 [