Comparison of Different Treatment Modalities for Type 1 Diabetes, Including Sensor-Augmented Insulin Regimens, in 52 Weeks of Follow-Up: A COMISAIR Study

Jan Šoupal, Lenka Petruželková, Milan Flekač, Tomáš Pelcl, Martin Matoulek, Martina Daňková, Jan Škrha, Štěpán Svačina, Martin Prázný, Jan Šoupal, Lenka Petruželková, Milan Flekač, Tomáš Pelcl, Martin Matoulek, Martina Daňková, Jan Škrha, Štěpán Svačina, Martin Prázný

Abstract

Objective: To compare different treatment modalities for patients with type 1 diabetes (T1D) based on real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG) combined with multiple daily injections (MDIs) or continuous subcutaneous insulin infusion (CSII).

Research design and methods: Sixty-five T1D patients were followed up for a year. Of these, 27 started RT-CGM as part of a sensor-augmented insulin regimen (SAIR); within this SAIR group, 15 subjects started sensor-augmented pump (SAP) therapy and the remaining 12 continued with MDIs (MDIs + RT-CGM). A second group of 20 patients initiated CSII without RT-CGM, while a third group of 18 subjects continued on MDIs and SMBG. The main endpoints were reduction of HbA1c, glycemic variability (GV), and incidence of hypoglycemia.

Results: After a year, the baseline mean HbA1c in the SAIR group (8.3%) decreased to 7.1% (P < 0.0001); both SAIR subgroups, SAP and MDIs + RT-CGM, showed comparable improvement. The CSII group also had reduced HbA1c (8.4% ± 0.9% vs. 7.9% ± 0.7%; P < 0.05). Both SAIRs were superior to MDIs (P = 0.002) and CSII (P = 0.0032). GV was also lowered, both in the SAIR (P < 0.0001) and CSII (P < 0.05) groups. Reduced incidence of hypoglycemia was observed only with SAIR (8% ± 4% vs. 6% ± 3%; P < 0.01).

Conclusion: Both SAIRs, SAP and MDIs + RT-CGM, provided significant and comparable decrease of HbA1c with concurrent reduction of hypoglycemia. This improvement was greater than that seen with CSII. The combination of RT-CGM and MDIs can be a suitable alternative to SAP for some patients.

Conflict of interest statement

Author Disclosure Statement No competing financial interests exist.

Figures

FIG. 1.
FIG. 1.
Comparison of different treatment strategies for patient with type 1 diabetes during 1 year of follow-up: effect on HbA1c. Mean glycated hemoglobin levels (%) at baseline and 3, 6, 9, and 12 months in all groups. Asterisks denote P < 0.05 for comparison between the sensor-augmented regimens group and the two SMBG groups (insulin pump and MDI therapy) at each time point. MDIs, multiple daily injections; SMBG, self-monitoring of blood glucose.
FIG. 2.
FIG. 2.
Comparison of the effect on HbA1c in patients with MDIs + real-time CGM therapy with sensor-augmented pump therapy and insulin pump therapy during the 52-week follow-up study. Mean glycated hemoglobin levels (%) at baseline and 3, 6, 9, and 12 months. P values <0.05 are statistically significant. CGM, continuous glucose monitoring; NS, not significant.

References

    1. Miller KM, Foster NC, Beck RW, et al. : T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015;38:971–978
    1. Nathan DM, Cleary PA, Backlund JY, et al. ; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643–2653
    1. Diabetes Control and Complications Trial Research Group. 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;329:977–998
    1. Šoupal J, Škrha J, Jr, Fajmon M, et al. : Glycemic variability is higher in type 1 diabetes patients with microvascular complications irrespective of glycemic control. Diabetes Technol Ther 2014;16:198–203
    1. Garg SK, Voelmle MK, Beatson CR, et al. : Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study. Diabetes Care 2011;34:574–579
    1. Bergenstal RM, Tamborlane WV, Ahmann A, et al. ; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311–320
    1. Battelino T, Conget I, Olsen B, et al. ; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia 2012;55:3155–3162
    1. Battelino T, Phillip M, Bratina N, et al. : Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care 34:795–800
    1. Garg SK, Schwartz S, Edelman SV: Improved glucose excursions using an implantable real-time continuous glucose sensor in adults with type 1 diabetes. Diabetes Care 2004;27:734–738
    1. Rodbard D, Jovanovic L, Garg S: Responses to continuous glucose monitoring in patients with type 1 diabetes using multiple daily injections and insulin pumps. Diabetes Technol Ther 2009;11:757–765
    1. Tamborlane WV, Beck RW, Bode BW, et al. ; Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464–1476
    1. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. Diabetes Care 2010;33:17–22
    1. Rodbard D: Interpretation of continuous glucose monitoring data: glycemic variability and quality of glycemic control. Diabetes Technol Ther 2009;11(Suppl 1):S-55–S-67
    1. Suh S, Kim JH: Glycemic variability: how do we measure it and why is it important? Diabetes Metab J 2015;39:273–282
    1. Rodbard D: Continuous glucose monitoring: a review of successes, challenges, and opportunities. Diabetes Technol Ther 2016;18 Suppl 2:S2-3–S2-13
    1. Tumminia A, Crimi S, Sciacca L, et al. : Efficacy of real-time continuous glucose monitoring on glycaemic control and glucose variability in type 1 diabetic patients treated with either insulin pumps or multiple insulin injection therapy: a randomized controlled crossover trial. Diabetes Metab Res Rev 2015;31:61–68
    1. Raccah D, Sulmont V, Reznik Y, et al. : Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care 2009;32:2245–2250
    1. Steineck I, Cederholm J, Eliasson B, et al. ; Swedish National Diabetes Register. Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18,168 people with type 1 diabetes: observational study. BMJ 2015;350:h3234.
    1. Liberman A, Buckingham B: Diabetes technology and the human factor. Diabetes Technol Ther 2016;18 Suppl 1:S101–S111
    1. Wong JC, Foster NC, Maahs DM, et al. ; T1D Exchange Clinic Network. Real-time continuous glucose monitoring among participants in the T1D Exchange clinic registry. Diabetes Care 2014;37:2702–2709

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