Do Smartphone Applications Hold the Secret to Reducing Hypoglycemia in Type 1 Diabetes?

Abstract

In this article in JDST, Feuerstein-Simon and colleagues examine use of a smartphone app in improving hypoglycemia awareness in type 1 diabetes (T1D). They conclude that their smartphone app, HypoMap™, has the potential to increase hypoglycemia awareness and reduce time spent with hypoglycemia in a cohort of long-standing patients with type 1 diabetes. The underlying assumption is that if patients can identify the precipitating cause, they can recognize symptoms better and potentially change behavior to prevent future hypoglycemic events. Potential limitations of this intervention include technical issues, patient burden from data entry with use of an app, and concern that this type of intervention may not be sustainable over time. While results of this pilot study suggest HypoMap may be an effective intervention in preventing hypoglycemia, further studies of increased sample size are needed to confirm these findings.

Hypoglycemia is a feared complication in T1D and remains a significant barrier to achieving optimal glycemic control in this population. In fact, more than 50% of patients with diabetes are fearful of hypoglycemia to some degree. The development of hypoglycemia unawareness becomes increasingly common with longstanding T1D and increases the chance of severe, sustained, and life threatening hypoglycemia. ¹ Current approaches to detecting and preventing hypoglycemia in the hypoglycemia unaware patient have focused on newer technologies such as sensor augmented insulin pumps and continuous glucose monitor (CGM) devices. These technologies aim to detect hypoglycemia in real time to alert the patient or identify trends towards hypoglycemia, allowing for cessation of insulin delivery. However, not all patients have access to or ability to use this technology. Few studies have attempted to increase patient awareness of hypoglycemic symptoms through use of a self-management technological approach (patient education combined with a smartphone application).

In this pilot study, ² the authors present a unique intervention to target hypoglycemia unawareness in long standing T1D. The primary objective of this study was to examine real time use of a mobile diabetes application (smartphone app) as well as its potential to reduce hypoglycemic events and time in hypoglycemia in adults with T1D. This intervention, based on blood glucose awareness training (BGAT), is a smartphone app that provides a platform for patients to record hypoglycemic symptoms, patient perception of hypoglycemia cause, and treatment. In order to participate, subjects were required to demonstrate a lack of full hypoglycemia awareness based off survey responses on the Clarke Hypoglycemia Unawareness survey. A CGM was then placed for 2 weeks to prove hypoglycemia and subjects were allowed to continue participation if they had at least 4 readings <70 mg/dL including 2 readings <55 mg/dL in the daytime hours. The subject received training on the HypoMap™ app and it was loaded on the smartphone. Hypoglycemic events alerted the app to prompt the participant to enter information related to the event. The authors hypothesize that tracking of symptoms can increase patient awareness of hypoglycemic events and “retrain” those individuals with reduced awareness to become more aware of these events.

Feuerstein-Simon and colleagues demonstrated that use of HypoMap had the potential to reduce daytime hypoglycemia in a subset of hypoglycemia unaware T1D patients. In the study, 9 and 6 participants (41% and 27% of total participants) reported improvement in recognizing and reducing hypoglycemia with use of the app at 6 and 12 weeks respectively. Blinded CGM data confirmed improvement 6 weeks following use of the app (reduction in time and episodes of glucose ⩽70 mg/dL and <54 mg/dL) in 10 participants (77% of CGM completes, 45% of total participants) and 8 (62% of completers, 36% of total participants) respectively. The reductions in hypoglycemia frequency and duration were seen during the daytime, supporting the idea that the app was responsible for the improvement. Lesser effects were seen at 12 weeks, possibly due to lower use of the app over time. Patient satisfaction with the app was generally good. At the 6 week time point, with 17 participants completing the survey, 13/17 participants agreed they were satisfied with the app’s ability to track hypoglycemia events, 9/17 agreed that the app helped them better recognize hypoglycemia events, and 6/17 agreed that they had less hypoglycemia with use of the app. At 6 weeks, 13/17 participants agreed the app was “easy to use.”

Although the HypoMap app allowed the subject to input information on hypoglycemic events, a limitation of the study is that the authors do not provide the data on the symptoms recorded by participants when prompted with a hypoglycemic event, nor the participants perceived causation of the event. This information is important when considering that BGAT helps hypoglycemia unaware patients better anticipate and recognize severe hypoglycemia. In order to suggest the app is responsible for improvement in hypoglycemia, it is important to demonstrate improved participant awareness of symptoms and causation during hypoglycemic events.

“Mobile health” is a term recognized by the World Health Organization referring to use of mobile applications and texting to aid in the management of medical conditions. ³ This behavioral approach is exciting given its potential to reeducate patients with T1D in real time using a smartphone app that is readily available and cost effective. Managing type 1 diabetes is challenging because of the frequency and complexity of self-management behaviors related to blood glucose monitoring, insulin administration, food intake, and physical activity. As a chronic medical condition requiring such consistent, complex care, it is the perfect example of a condition in which real-time use of a medical app could be effective in improving outcomes. There are currently over 1500 diabetes apps available on the two largest app marketplaces—iTunes and Google Play. ⁴ These apps vary in functionality, from simple (recording blood sugars and insulin doses, providing reminders to patients) to more complex functionalities such as insulin dose recommendations and blood glucose predictions. Although app developers make claims regarding promising clinical outcomes of these apps, very few of these apps have been studied for safety and efficacy and there is very little evidence that use of these apps actually improves patient outcomes (eg, reduction in HbA1c levels or hypoglycemia).^4,5 A recent report from the Agency for Healthcare Research and Quality (AHRQ) investigated approximately 280 commercially available phone apps for management of diabetes. Of these apps, only 11 had been studied for efficacy, and only 5 were shown to improve glycemic control as demonstrated by a reduction in HbA1c. Only 2 of the 5 apps shown to improve control were studied in T1D. The authors concluded that although use of a phone app is promising; the current studies were not of high enough quality to prove improved efficacy with use of an app. In addition, none of the studies evaluated use of the app long term, making it unclear whether this potential improvement could be sustained. ⁶

The potential promise of smartphone apps is clear. Apps can provide patients and providers with more objective data in real time. These data can help patients manage their behaviors better to result in more effective diabetes management. Smartphone apps are appealing given their portability, cost-effectiveness, transmission capabilities, and ability to facilitate individualized feedback. However, we need more high-quality evidence, such as from randomized controlled trials, that use of smartphone apps can improve diabetic control and reduce hypoglycemia. In addition, longer term studies are needed to demonstrate sustainability.

Conclusion

Feuerstein-Simon and colleagues should be commended in their efforts to target hypoglycemia in a way that has the potential to impact a large number of patients in a real-life clinical setting. Further studies are needed to demonstrate the usability (technical and adherence concerns), efficacy, and sustainability of this smartphone app.