Clinical Evidence

These benefits on both Glycemic control & QoL are supported by growing evidence of Connectivity in the insulin management

Clinical Outcomes

Connected delivery devices have been associated with improved glycemic control¹:

Improved Time In Range
(increase in mean TIR of 1.9 hours per day, or TIR increased 8.5% of day)¹
Reduced HbA_1c levels
(greater reduction in HbA_1cfrom baseline (−0.98% vs −0.72%) when receiving alarms/reminders)²
Reduced missed doses (by 43%)¹

Quality of life

Connected delivery devices have good levels of patient satisfaction² and are well perceived by patients with diabetes³:

Easier to record their diabetes-related information
Ability to keep all insulin and diabetes data in a single location
Ability to be alerted when all insulin in the body had been metabolized³

References

Adolfsson et al., 2020, Diabetes Technol Ther., 22(10):709-718
Galindo et al., 2023, J Diabetes Sci Technol., 17(1):201-207
Naïditch et al., 2023, Diabetes Ther 14, 303–318

Connected caps integrate data on insulin injections into diabetes management platforms

References

Tejera-Perez C, et al. Diabetes Ther 2023;14:1077–91;
Jamdade V, et al. Value Health 2022;25: S31

Increased TIR and fewer missed bolus injections after the introduction of a connected insulin

In two analyses, improvement in glycaemic outcomes and concordance with bolus injections were seen in people using connected insulin pens/caps

Connected pen¹

In people with T1D, a recent study has shown potential improvements in TIR and fewer missed bolus insulin injections after the introduction of a connected pen

Connected cap²

A recent pilot study assessed the effectiveness of a connected cap and found that device use was associated with a decrease in mean glucose and increased TIR in people with T1D

Connected cap use was also associated with a reduction in the number of missed or mistimed insulin injections per month

References

Observational study investigating whether the connected NovoPen^®6 could influence insulin regimen management and glycemic control in people with T1D on a basal-bolus insulin regimen with CGM in a real-world setting (N=94); Adolfsson P, et al. Diabetes Technol Ther 2020;22:709–18;
Randomized, single-center, pilot study assessed the clinical impact of Insulclock^® on glycemic control and variability, treatment concordance, and satisfaction in people with uncontrolled T1D (N=16); Gomez-Peralta F, et al. Diabetes Technol Ther 2020;22:686–90.

Real-world effectiveness of a connected system in adults with type 2 diabetes

Overview: evaluation of real-world effectiveness in people with type 2 diabetes using basal insulin^*and a connected cap (Mallya) and app (Health2Sync)

Research design and population

This retrospective cohort study evaluated 83 people with type 2 diabetes (≥20 years), registered on app and initiated connected cap use (index date) for a new/existing basal insulin^* regimen
In this study, 32 (38.6%) new basal insulin^* users (i.e., who initiated basal insulin^* during the identification period) and 51 (61.4%) previous basal insulin^* users (i.e., who had an existing basal insulin^*regimen prior to the identification period) were evaluated

Study methodology

Eligible participants with type 2 diabetes were active on the app, used the connected cap and had more than one HbA_1c value in the baseline (90 days pre-index) and follow-up periods (90–120 days post-index)
Participants were identified from 05/01/2021 to 05/31/2022 (or 90 days prior to end of latest available data) and the study was conducted from 01/31/2021 to 08/31/2022 (or end of latest available data)
Data were collated from the app and web platform

Outcomes

Primary outcomes
- HbA_1cchange (baseline to follow-up) and
- HbA_1c goal achievement
Secondary outcomes included change in
- Fasting plasma glucose and
- Basal insulin^* dose
Safety outcomes included
- Hypoglycaemic event rate
  (any hypoglycaemia and nocturnal hypoglycaemia)^†

*The basal insulin used within this study was Gla-300. The connected cap and app used in this study were the Mallya cap and the Health2Sync app.
^†Note: the study’s safety outcomes were not reported in the poster presented at ATTD 2023.
Wang CY et al. Poster 487 presented at ATTD 2023.
Mallya cap is an older version of SoloSmart that is connected to Sanofi SoloStar Pen

Significant HbA_1c reduction after initiation of connected cap and diabetes management platform

Mean HbA_1c decreased significantly from baseline to follow-up in both groups

^*Indicates statistically significant difference (p<0.05). Hypoglycemia was experienced by 27.7% of people with T2D, 1.2% experienced a nocturnal hypoglycaemic event in the hours 00:00–05:59 and 15.7% experienced a hypoglycaemic event in the expanded nocturnal window 22:00–07:00. Please note, the study’s safety outcomes were not reported in the poster presented at ATTD 2023.

References

Wang CY, et al. Presented at ATTD 2023. Poster #487.

Greater target achievement in new basal insulin users vs previous insulin users

HbA_1c <7 % at baseline and follow-up

HbA_1c reduction >0.5 %

HbA_1c reduction >0.5% was achieved by 65.6% of new basal insulin users and 29.4% of previous basal insulin users

References

Wang CY, et al. Poster presentation at ATTD 2023;#487;

Recent guidelines highlight how connected devices may support diabetes management for PWD on insulin therapy

ADA Standards of Care 2024¹
Connected insulin pens can be helpful for diabetes management and may be used in people with diabetes using injectable therapy

ADA/EASD Consensus Statements (2021 and 2022)^2,3
The potential roles of connected devices for diabetes management have been noted in the recent ADA/EASD Consensus Statements:

T1D: Technology (including connected insulin pens) can support more frequent communication between the PWD and their HCP
T2D: For those needing insulin as part of their treatment, connected insulin pens and CSII are available

AACE Guidelines 2021⁴
Connected pens may be recommended for all persons with diabetes who are treated with intensive insulin management, with 3 or more injections per day and who are not on insulin pump therapy, in whom an assessment of insulin dosing may help the person with diabetes and the clinician to further optimize the insulin regimen and avoid the stacking of rapid-acting insulin doses that could lead to hypoglycemia

AACE, American Association of Clinical Endocrinology; CSII, continuous subcutaneous insulin infusion; EASD, European Association for the Study of Diabetes.

References

Volume 47 Issue Supplement_1 | Diabetes Care | American Diabetes Association (diabetesjournals.org).
Holt RIG, et al. Diabetes Care 2021;44:2589–625;
Davies MJ, et al. Diabetes Care 2022;45:2753–86;
Grunberger G, et al. Endocr Pract 2021;27:505–37.

Impact of Connected Insulin Solutions

Personalized Support to improve Self-management skills of Patients

Reminders of BG monitoring & insulin dose injection
Encourage healthy habits - personalized, informative and educational leading to better behavior
Easy access to HCP-based recommended doses: Optimum titration in shorter time
Help reduce the day-to-day disease burden***

Complete and accurate patients’ data for evidence-based decisions

Visualized dashboard help reading trends and patients’ compliance, not numbers
Improve insulin self-management
Practical and emotional support to patients between consultations
Reduced Healthcare Professional Burden³

Accurate data on insulin
dosing & BG levels

Ability to track Adherence
Administering the right dose – too high lead to hypos & too low lead to hyper/Ka
Minimize Causes of BG variation among patients & reduce cost of complications

* Research Partnership. HCP/Patient Qualitative/Quantitative Market Research. May 2018 (US, IT, GE)
SoloSmart is under SFDA registration review
**Insulin Connected Device Assessment – USA Mallya. MR Survey. Aug.2019
*** Automated BG & Dose recording via BT connected devices
The INNOVATE Study showed that patients adjusting their insulin dose with a home-based digital titration tool visited their Healthcare Professional less frequently compared with those receiving Enhanced Usual Therapy (EUT), thus reducing the demand on physician time and resources.

Connected insulin caps may further help to foster effective clinical conversations

Before use of connectivity