Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management

Satish K Garg, Viral N Shah, Halis K Akturk, Christie Beatson, Janet K Snell-Bergeon, Satish K Garg, Viral N Shah, Halis K Akturk, Christie Beatson, Janet K Snell-Bergeon

Abstract

Introduction: The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.

Methods: The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.

Results: Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32).

Conclusion: The use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.

Clinical trial registration: ClinicalTrials.gov: NCT01825382.

Funding: Sanofi.

Keywords: Continuous glucose monitoring; Diabetes; Glucometer; Hypoglycemia; Mobile technology; Self-monitoring of blood glucose; Type 1 diabetes; iBGStar; iPhone.

Figures

Fig. 1
Fig. 1
Study design. Asterisk CGM blinded insertions 7 days prior to visit, plus sign phone visit
Fig. 2
Fig. 2
Change in A1c by study group at 3 and 6 months
Fig. 3
Fig. 3
Percentage of time spent hypoglycemic (

References

    1. Dabelea D, Mayer-Davis EJ, Saydah S, et al. Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA. 2014;311(17):1778–1786. doi: 10.1001/jama.2014.3201.
    1. Imperatore G, Boyle JP, Thompson TJ, et al. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care. 2012;35(12):2515–2520. doi: 10.2337/dc12-0669.
    1. Shah VN, Shoskes A, Tawfik B, Garg SK. Closed-loop system in the management of diabetes: past, present, and future. Diabetes Technol Ther. 2014;16(8):477–490. doi: 10.1089/dia.2014.0193.
    1. Majidi S, Driscoll KA, Raymond JK. Anxiety in children and adolescents with type 1 diabetes. Curr Diab Rep. 2015;15(8):47. doi: 10.1007/s11892-015-0619-0.
    1. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015;38(6):971–978. doi: 10.2337/dc15-0078.
    1. Miller KM, Beck RW, Bergenstal RM, et al. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013;36(7):2009–2014. doi: 10.2337/dc12-1770.
    1. Garg S, Hirsch IB. Self-monitoring of blood glucose. Int J Clin Pract Suppl. 2010;166:1–10. doi: 10.1111/j.1742-1241.2009.02271.x.
    1. American Diabetes Association Standards of medical care in diabetes-2015. Diabetes Care. 2015;38:S1–S90.
    1. Spollet GR. Self-monitoring of blood glucose: an underutilized tool. Clin Diabetes. 2010;28:127–129. doi: 10.2337/diaclin.28.3.127.
    1. Moser EG, Morris AA, Garg SK. Emerging diabetes therapies and technologies. Diabetes Res Clin Pract. 2012;97(1):16–26. doi: 10.1016/j.diabres.2012.01.027.
    1. Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Int Res. 2013;15(11):e235.
    1. Overland J, Abousleiman J, Chronopoulos A, Leader N, Molyneaux L, Gilfillan C. Improving self-monitoring of blood glucose among adults with type 1 diabetes: results of the Mobile™ study. Diabetes Ther. 2014;5(2):557–565. doi: 10.1007/s13300-014-0092-9.
    1. Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987;10(5):617–621. doi: 10.2337/diacare.10.5.617.
    1. Nathan DM, Genuth S, Lachin J, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977–986. doi: 10.1056/NEJM199309303291401.
    1. Garg SK. Role of emerging new technologies. Diabetes Technol Ther. 2008;10(5):413–414. doi: 10.1089/dia.2008.0069.
    1. Ramljak S, Musholt PB, Schipper C, et al. The precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors. Expert Opin Med Diagn. 2013;7(6):511–516. doi: 10.1517/17530059.2013.839984.

Source: PubMed

3
Sottoscrivi