Tandem’s Control-IQ Cleared for Ages 6-13: Automated Insulin Delivery for Children!

This content originally appeared on diaTribe. Republished with permission.

By Divya Gopisetty, Hanna Gutow, and Albert Cai

In exciting news, Tandem announced expanded clearance for the hybrid closed loop Control-IQ. The system is now available for children ages 6-13

The FDA cleared Tandem’s automated insulin delivery (AID) system, Control-IQ, for children ages 6-13, last week in the US. This system is designed to increase time in range for users and it does – see below for the data!

To date, the only other hybrid closed loop system available for children is Medtronic’s MiniMed 670G, which is approved for children seven years and older. Control-IQ is the first system with automatic correction boluses and no fingerstick calibration (thanks to the Dexcom G6 sensor that it uses).

Control-IQ launched in January of this year for people 14 years and older. Since then, more than 40,000 t:slim X2 pump users have upgraded their pump software to Control-IQ. We saw very positive real-world data presented at ADA this year – in the first 30 days using Control-IQ, users’ time in range increased by 2.4 hours per day, and individuals were in active closed loop 96% of the time.

At the ATTD conference in February, the trial for Control-IQ in children presented strong results. Results from that trial were used to get this week’s FDA clearance. In that trial, we learned that:

  • Children using Control-IQ spent 67% time in range, compared to 55% for children using a sensor-augmented pump. This is a massive difference that equals nearly three more hours in range each day.
  • Children using Control-IQ reached 80% time in range overnight, compared to 54% in the control group – similarly, this change is even bigger, at over six hours more daily time in range.

Control-IQ still should not be used in children under the age of six, in people who require less than ten units of insulin per day, and in children who weigh less than 55 pounds.

For more information on the system, check out Kerri Sparling’s Test Drive of Control-IQ where her time in range improvement was quite impressive! You can also Katie Bacon’s piece on one family’s takeaways (her own!) from the first month of their teenage daughter using Control-IQ.

Source: diabetesdaily.com

New Research: Hybrid Closed-Loop System Outcomes (ADA 2020)

Technology is truly changing the lives of many people with diabetes across the world. Advancements continue in many areas, including the development and testing of various automated insulin delivery systems.

The MiniMed 670G insulin pump system is the first of it’s kind in providing automatic insulin delivery adjustments based on continuous glucose monitoring (CGM) data. Now, two recent research studies, the results of which were just presented this weekend at the American Diabetes Association (ADA) 80th Scientific Sessions, are highlighting the positive outcomes of the system for young and adults patients.

Outcomes in Adult Patients

Dr. Stephanie Kim, MD, MPH, from the University of San Francisco, CA, presented the results of a single-center research study in adult patients with type 1 diabetes. The researchers enrolled 52 patients (47% female, average age 46 +/-12 years, average diabetes duration of 27 +/- 15 years) utilizing the Medtronic 670G system and started “Automode” delivery of insulin between 2017 and 2019, in an effort to evaluate the impact of automatic delivery on glycemic outcomes.

The study subjects were stratified into two groups, depending on baseline blood glucose levels (defined as A1c level of higher than 7.6% or lower than or equal to 7.5%). The A1c levels were evaluated at baseline (before starting Automode) and again approximately 17 months after starting Automode.

The data revelated that while the A1c level did not change significantly in patients in the lower A1c cohort, there was improvement in the group with baseline A1c>7.6%. These patients improved their A1c, on average, from 8.3% to 7.8% using this system.

Outcomes in Youth

Dr. Goran Petrovski, MD, PhD, of Sidra Medicine in Qatar, reported on the results of an observational study of children and young adults with type 1 diabetes who used multiple daily insulin injections (MDI) and switched to the MiniMed 670G hybrid closed-loop system. A total of 42 patients (ages 7-18, mean age 12 years) were enrolled in the study.

Excitingly, the study outcomes demonstrated considerable improvements to the average A1c levels (8.4% at baseline to 6.7% at 3-months follow-up, and 6.9% at 6-months follow-up) after initiating the hybrid closed-loop system therapy. Also, the time-in-range (defined in this study as blood glucose levels between 70-180 mg/dL) improved considerably with the use of this technology. Notably, no instances of diabetic ketoacidosis (DKA) or severe hypoglycemia were reported. The authors declared no conflict of interest and concluded that “children and adolescents with T1D can successfully initiate the HCL system, achieve and maintain better glycemic control than previous MDI regimen.”

Petrovski et. al. (Presented at ADA 2020)

Conclusions

Technology that can help people with diabetes better manage their blood glucose levels continues to improve. Notably, while the glycemic improvement in youth who transitioned from MDI to the automated system were considerable, the improvements were much more modest in the study on adults using this system who switched to Automode. Altogether, the data highlight the potential of technology to improve outcomes, while also revealing that technology use (at least as it stands today) is generally not enough on its own, to achieve optimal results. Patient education regarding diet, exercise, and the numerous intricacies of dosing insulin remain central to optimizing outcomes.

Source: diabetesdaily.com

Search

+