FDA Clears Glooko’s Long-Acting Insulin Titration System

Glooko, developer of diabetes data management technology, has received U.S. Food and Drug Administration clearance for its Mobile Insulin Dosing System (MIDS) for the titration of long-acting insulin for type 2 diabetics. Glooko’s MIDS is the first insulin titration application accessible through a unified diabetes management platform, which provides a complete program for diabetes management.
 
The system includes access to a patient’s blood glucose (BG) data directly from their glucose meter so people with diabetes (PWDs) do not have to manually enter their fasting blood glucose, and healthcare providers (HCPs) access accurate diabetes data in the MIDS module.¹ MIDS analyzes a patient’s fasting blood glucose levels and recommends insulin dose adjustments based on the HCP’s pre-configured treatment plan and/or published clinical guidelines so patients can quickly and easily get to their optimal insulin dose. To enhance adherence, MIDS includes customizable in-app reminders to check fasting blood glucose and to take insulin.
 
Poor understanding of insulin therapy by people with diabetes, combined with clinical inertia driven by a lack of knowledge, education and time, has negatively impacted the success of insulin therapy.² Less than 50 percent of PWDs on long-acting insulin have achieved their target glycemic outcomes.³ At the same time, patient education and communication on insulin titration has proven clinical benefits.⁴
 
While adherence to insulin therapy is sub-optimal, clinical inertia by physicians—resistance to initiate and/or escalate insulin therapy—is also a barrier to achieving glycemic control for PWDs. Although step-wise intensification of diabetes therapy is recommended by both national and international guidelines,⁵ physicians in the United States tend to delay the initiation of insulin therapy compared to physicians from other countries.⁶
 
The prevalence of mobile technologies provides a way to support and educate patients on insulin in a continuous and contextual manner. With MIDS, Glooko has set out to ease and improve adherence to insulin therapy and drive overall better health outcomes among people with type 2 diabetes.
 
“Managing long-acting insulin can be a challenge for people with diabetes because it requires patients to regularly change their doses based on their own calculations using fasting glucose values. This can be daunting and unreliable,” said Dr. Michael Greenfield, chief medical officer at Glooko. “I am excited that Glooko can now offer MIDS, which helps clinicians support their patients in safely and rapidly attaining optimal glycemic levels. In a pre-market study, I used MIDS with my patients and was able to witness both improvements in glucose control and how happy patients were to have an easy tool to help them titrate their insulin dose on their mobile phones.”
 
Glooko invested in 18 months of close collaboration with clinical experts around the world to ensure MIDS is market-ready. Many rounds of user experience design reviews, human factors studies, pre-market programs and feedback sessions have culminated in the delivery of MIDS. Results, including some from these studies, can be found in an infographic recently presented at the Diabetes Technology Society meeting.
 
Glooko provides insights into diabetes by enabling both people with diabetes (PWDs) and their care teams with technology to understand and manage diabetes care. Its self-management mobile app automatically uploads data from devices including blood glucose meters, insulin pumps, CGMs and several fitness and activity trackers, providing timely and verified data and enabling PWDs and care teams to correlate it with diet, exercise, medication and other data. The company provides care teams with an easy office data upload solution and a population health app so they can support PWDs during and in-between office visits. Glooko products are used by 7,000 clinics and over 1.5 million PWDs in 23 countries across 15 languages.

References
1. Kalergis, et al. (2006) Science Direct; Accuracy and Reliability of Reporting Self-monitoring of Blood Gluocse Results.
2. Diabetes Care. 2010;33(2):240-5; Patient Prefer Adherence. 2008;2:87-95; Diabetes Med. 2012;29(5):682-9; Diabetes Care. 2005;28(1):78-83.
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889324/
4. J Multidiscip Healthc. 2014;7: 267–282.
5. Diabetes Educ. 2011;37(1):111-23; J Gen Intern Med. 2007;22(4):453-8.
6. Diabetes Care. 2005;28(11):2673-9; Endocrine Practice: February 2016, Vol. 22, No. 2, pp. 151-161.