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Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion.
Clin Ther. 2009 May; 31(5):980-7.CT

Abstract

BACKGROUND

Reducing postprandial hyperglycemia and hypoglycemia is a major challenge in the treatment of patients with diabetes. Studies suggest that heating the insulin injection site may accelerate insulin absorption. InsuPatch (InsuLine Medical Ltd., Petach-Tikva, Israel) is a device intended to accelerate subcutaneous insulin delivery using an insulin pump by locally warming the infusion site.

OBJECTIVE

The aim of this study was to assess the effect of the InsuPatch device on the pharmacokinetics of short-acting insulin analogues and on postprandial glycemia.

METHODS

This was an open-label, randomized, 2-period, 1-way crossover study using a meal tolerance test (MTT) protocol in subjects with type 1 diabetes mellitus aged 18 to 65 years with glycosylated hemoglobin (HbA(1c)) of 6% to 12%, who were using continuous subcutaneous insulin infusion (CSII) therapy (insulin lispro or aspart). A bolus of insulin 0.15 U/kg was delivered immediately before a standardized liquid meal. The effect of the device on insulin absorption and postprandial glucose excursions was tested by measuring blood glucose and insulin concentration profiles with and without the operation of the device. Adverse events (AEs) were monitored during the 2 study visits. The infusion site was visually inspected at the end of each study. All AEs were recorded in the case-report form.

RESULTS

The MTT protocol was performed in 17 white patients with type 1 diabetes (sex, male/female, 7/10; mean age, 31.8 years [range, 18-53 years]; mean body mass index, 25.6 kg/m(2) [range, 20.0-39.4 kg/m(2)]; and mean HbA(1c), 7.1% [range, 5.8%-9.3%]). The mean (SD) postprandial glucose excursion AUC at 120 minutes after the meal was significantly reduced in the group that used the device compared with the group that did not (104 [65] vs 155 [56] mg/dL/h; P < 0.005). Plasma insulin was measured randomly in 9 of the 17 subjects. Use of the device was associated with significant reductions in mean (SD) T(max) (45 [28] vs 78 [35] minutes) and time to half-maximum concentration (T(50%max)) (20 [11] vs 28 [10] minutes; both, P < 0.05). Insulin AUC increased significantly in the group that used the device compared with the group that did not at 30 (21 [6] vs 33 [16] mU/L/h), 60 (55 [12] vs 80 [28] mU/L/h), and 90 (93 [19] vs 118 [31] mU/L/h) minutes after administration (all, P < 0.05). Cmax also increased significantly (118 [35] vs 86 [16] mU/L [38%]; P < 0.05).

CONCLUSION

In this pilot study, use of the InsuPatch was associated with significant decreases in T(max) and T(50%max) and increases in insulin AUC and C(max) of subcutaneous infused rapid-acting insulin analogues, resulting in a lower postprandial glucose excursion in these patients with type 1 diabetes mellitus treated with CSII.

Authors+Show Affiliations

The Diabetes Center, Hadassah Hebrew University School of Medicine, Jerusalem, Israel. ntv502@netvision.net.ilNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19539098

Citation

Raz, Itamar, et al. "Effect of a Local Heating Device On Insulin and Glucose Pharmacokinetic Profiles in an Open-label, Randomized, Two-period, One-way Crossover Study in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion." Clinical Therapeutics, vol. 31, no. 5, 2009, pp. 980-7.
Raz I, Weiss R, Yegorchikov Y, et al. Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion. Clin Ther. 2009;31(5):980-7.
Raz, I., Weiss, R., Yegorchikov, Y., Bitton, G., Nagar, R., & Pesach, B. (2009). Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion. Clinical Therapeutics, 31(5), 980-7. https://doi.org/10.1016/j.clinthera.2009.05.010
Raz I, et al. Effect of a Local Heating Device On Insulin and Glucose Pharmacokinetic Profiles in an Open-label, Randomized, Two-period, One-way Crossover Study in Patients With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Clin Ther. 2009;31(5):980-7. PubMed PMID: 19539098.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of a local heating device on insulin and glucose pharmacokinetic profiles in an open-label, randomized, two-period, one-way crossover study in patients with type 1 diabetes using continuous subcutaneous insulin infusion. AU - Raz,Itamar, AU - Weiss,Ram, AU - Yegorchikov,Yevgeny, AU - Bitton,Gabriel, AU - Nagar,Ron, AU - Pesach,Benny, PY - 2009/04/10/accepted PY - 2009/6/23/entrez PY - 2009/6/23/pubmed PY - 2009/8/29/medline SP - 980 EP - 7 JF - Clinical therapeutics JO - Clin Ther VL - 31 IS - 5 N2 - BACKGROUND: Reducing postprandial hyperglycemia and hypoglycemia is a major challenge in the treatment of patients with diabetes. Studies suggest that heating the insulin injection site may accelerate insulin absorption. InsuPatch (InsuLine Medical Ltd., Petach-Tikva, Israel) is a device intended to accelerate subcutaneous insulin delivery using an insulin pump by locally warming the infusion site. OBJECTIVE: The aim of this study was to assess the effect of the InsuPatch device on the pharmacokinetics of short-acting insulin analogues and on postprandial glycemia. METHODS: This was an open-label, randomized, 2-period, 1-way crossover study using a meal tolerance test (MTT) protocol in subjects with type 1 diabetes mellitus aged 18 to 65 years with glycosylated hemoglobin (HbA(1c)) of 6% to 12%, who were using continuous subcutaneous insulin infusion (CSII) therapy (insulin lispro or aspart). A bolus of insulin 0.15 U/kg was delivered immediately before a standardized liquid meal. The effect of the device on insulin absorption and postprandial glucose excursions was tested by measuring blood glucose and insulin concentration profiles with and without the operation of the device. Adverse events (AEs) were monitored during the 2 study visits. The infusion site was visually inspected at the end of each study. All AEs were recorded in the case-report form. RESULTS: The MTT protocol was performed in 17 white patients with type 1 diabetes (sex, male/female, 7/10; mean age, 31.8 years [range, 18-53 years]; mean body mass index, 25.6 kg/m(2) [range, 20.0-39.4 kg/m(2)]; and mean HbA(1c), 7.1% [range, 5.8%-9.3%]). The mean (SD) postprandial glucose excursion AUC at 120 minutes after the meal was significantly reduced in the group that used the device compared with the group that did not (104 [65] vs 155 [56] mg/dL/h; P < 0.005). Plasma insulin was measured randomly in 9 of the 17 subjects. Use of the device was associated with significant reductions in mean (SD) T(max) (45 [28] vs 78 [35] minutes) and time to half-maximum concentration (T(50%max)) (20 [11] vs 28 [10] minutes; both, P < 0.05). Insulin AUC increased significantly in the group that used the device compared with the group that did not at 30 (21 [6] vs 33 [16] mU/L/h), 60 (55 [12] vs 80 [28] mU/L/h), and 90 (93 [19] vs 118 [31] mU/L/h) minutes after administration (all, P < 0.05). Cmax also increased significantly (118 [35] vs 86 [16] mU/L [38%]; P < 0.05). CONCLUSION: In this pilot study, use of the InsuPatch was associated with significant decreases in T(max) and T(50%max) and increases in insulin AUC and C(max) of subcutaneous infused rapid-acting insulin analogues, resulting in a lower postprandial glucose excursion in these patients with type 1 diabetes mellitus treated with CSII. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/19539098/Effect_of_a_local_heating_device_on_insulin_and_glucose_pharmacokinetic_profiles_in_an_open_label_randomized_two_period_one_way_crossover_study_in_patients_with_type_1_diabetes_using_continuous_subcutaneous_insulin_infusion_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(09)00156-8 DB - PRIME DP - Unbound Medicine ER -