A new software titrates the next insulin dose on the basis of the measured blood sugar patterns and recommends it directly to the patient. The effectiveness of this technological support method was proven in a randomized study.
Do you know Hygieia? Of course, this is one of the daughters of Asklepios, a goddess of health and patron saint of pharmacists. But it is also the name of a small US-American company based in Michigan, which describes itself as a "digital insulin enhancement company". Their product: the d-Nav Insulin Guidance System, which is specifically designed to support patients with type 2 diabetes in their insulin therapy. True to the slogan on the company website: "We think insulin therapy should be easier."
The core of the d-Nav System is a software that uses an algorithm to determine the patterns of glucose levels and uses them for dose calculation. In the hardware version, the blood glucose measurement is carried out with a small hand-held device whose display then automatically shows the adjusted insulin dose for the next application. The patient thus receives a direct recommendation for both basal and meal (also known as mealtime, prandial or bolus) insulin - in contrast to the insulin dosing systems and titration algorithms previously available.
The d-Nav System is not bound to any particular insulin or therapeutic regimen. The device is not yet freely available, so far apparently only the software is approved in the USA. It has so far been used in southwestern Michigan and Northern Ireland, where there is a Hygieia branch. In February, the FDA approved a smartphone app for the d-Nav System for this purpose. According to Hygieia’s press release, this is the first insulin management app that can titrate individual doses for all types of insulin regimens in type 2 diabetes and report the recommendation directly to the patient. The app can be connected to all cloud-based blood glucose meters, according to the provider.
How well the d-Nav System works as a hand-held device was recently investigated in a 6-month study with RCT design at three diabetes centers in the USA - and published with a positive result in The Lancet (source 1). The additional use of d-Nav was compared with the professional diabetes counseling alone, which took place during the 6-month study period with three presence contacts and four telephone contacts. The 181 participants with type 2 diabetes were between 21 and 70 years old and had HbA1c values between 7.5% and 11% (an average of 8.7% in the intervention group and 8.5% in the control group).
The results:
First author Dr. Richard Bergenstal of the Park Nicollet International Diabetes Center in Minneapolis (Minnesota, USA) presented the results in February at the ATTD 2019 (Advanced Technologies & Treatments for Diabetes) in Berlin (sources 2 and 3). The diabetologist, who also acts as a medical advisor to Hygieia, pointed out that according to register studies only about 30% of insulinized TD2 patients achieve HbA1c below 7%. In clinical studies, the figure is about 50%.
Dr. Bergenstal admitted that his own clinic was also struggling with the care of insulinized type 2 diabetics. "Most centers need help." However, he does not see the solution to the problem in giving up insulin in favor of new drugs, but in the more effective use of insulin through close therapy adjustments.
"Insulin needs constant change. It really looks like people go through cycles. The frequent adjustment of the insulin dose makes the difference, and this system automates it - not the insulin administration, but the recommendation. That's what it takes to gain control," Bergenstal is quoted on Medscape.
The diabetologist and technology expert Prof. David Ahn (Newport Beach, California), who was asked to comment on the lecture, pointed out the "immense problem" of clinical inertia, especially when it comes to initiating and managing insulin therapy. "Seeing a patient only every three months for insulin adjustment is not ideal ... That's why it's really exciting. It allows rapid dose adjustments and that can't be underestimated."
But Prof. Ahn also made a little reality check by describing the observed weight gain as a "great weakness" and criticizing the d-Nav approach's lack of a holistic perspective. The sole focus on the insulin dose, without considering exercise and nutrition, is of course somewhat short-sighted.
However, the algorithm is not intended to replace doctors and diabetes advisors, but to support patients' self-management. In view of the reality of the practice, a closely-knit and highly monitored therapy remain an unattainable ideal in most cases. There are other patients who do not trust an algorithm, but only their doctor, and who are grateful for more attention.
In view of the limited time resources in practice, we welcome functioning technical assistance - as a voluntary offer to be used according to individual needs.
Sources:
1. Bergenstal RM et al. Automated insulin dosing guidance to optimize insulin management in patients with type 2 diabetes: a multicentre, randomized controlled trial. Lancet 2019;16:1138-48
2. d-Nav Insulin Dosing System Improves Improves HbA1c in Type 2 Diabetes. Medscape, 04.03.2019. (medscape.com; accessed 09.07.2019)
3. metabolism control by algorithm? Medical Tribune, 05.06.2019. (medical-tribune.de; accessed 09.07.2019)
4. Evans ML, Golubic R. Technology to overcome clinical inertia in insulin therapy. Lancet 2019;393(10176):1078-80. doi:10.1016/S0140-6736(19)30416-7