Safety of Insulin Glulisine when Given by Continuous Subcutaneous Infusion Using an External Pump in Patients with Type 1 Diabetes
Abstract
This twelve-week, European, multicenter, controlled, open-label, randomized (1 : 1), parallel-group trial compared the safety of insulin glulisine with insulin as part used in continuous subcutaneous insulin infusion. Patients with type 1 diabetes (n=59) and continuous subcutaneous insulin infusion experience (mean values: HbA1c 6.9 % [insulin glulisine: 6.8 % VS. insulin as part: 7.1 %]; age 45.8 years; body mass index 26.0 kg/m2) were enrolled. HbA1c levels at endpoint (insulin glulisine: 7.0 % VS. insulin as part: 7.2 %), daily insulin doses, blood glucose profiles and adverse event rates were similar in both groups. The median (minimum-maximum) catheter occlusion rate was low for insulin glulisine and insulin as part (0 [0 - 0.7] VS. 0 [0 - 1.1] occlusions/month. Unexplained hyperglycemia occurred in six insulin glulisine-treated patients and twelve insulin as part-treated patients. Patients were expected to change their catheters every 2 days (15 changes/month); the catheter change rate was similar for insulin glulisine and insulin as part (14.1 VS. 14.8 changes/month). The frequency of infusion site reactions and hypoglycemia, and the time between catheter changes were similar for both insulin forms. Diabetic ketoacidosis was not reported. This study supports the safety of insulin glulisine in continuous subcutaneous insulin infusion administered via an external pump in type 1 diabetes.
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In that 2002 study, only a small percentage of clogs or blockages coincided with a hyperglycemic episode: 9% (15/158), 6% (5/81), and 7% (9/136) for ASP, LIS, and BRI, respectively.
“Only a small percentage of clogs or blockages (9% [15/158], 6% [5/81], and 7% [9/136] for ASP, LIS, and BRI, respectively), coincided with a hyperglycemic episode.7”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [7]
In that 2002 study, 25%, 36%, and 22% of subjects in the ASP, LIS, and BRI groups, respectively, reported four or more clogs or blockages of the pump or IIS during the treatment period.
“A subset of subjects (25%, 36%, and 22% of those in the ASP, LIS, and BRI groups, respectively) reported four or more clogs or blockages of the pump or IIS during the treatment period.”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [7]
In a 2002 follow-up study, 146 subjects with type 1 diabetes were randomized to insulin aspart (ASP), LIS, or BRI in insulin pumps over 16 weeks.
“In a follow-up study reported in 2002 by some of the same investigators, occlusion rates were reported with the use of either insulin aspart (ASP), LIS, or BRI in insulin pumps, over 16 weeks among 146 subjects with type 1 diabetes who were randomized to one of these types of insulin.”
From Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block (2017) · cites this paper as [7]
Cites
Bode, B., Weinstein, R., Bell, D., McGill, J., Nadeau, D., Raskin, P., Davidson, J., Henry, R., Huang, W.-C., & Reinhardt, R. R. (2002) · Diabetes Care · doi:10.2337/diacare.25.3.439 · Cited by 148 · see citing works
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Home, P. D. (2012) · Diabetes, Obesity and Metabolism · doi:10.1111/j.1463-1326.2012.01580.x · Cited by 212 · see citing works
Schmid, V., Hohberg, C., Borchert, M., Forst, T., & Pfützner, A. (2010) · Journal of Diabetes Science and Technology · doi:10.1177/193229681000400429 · Cited by 97 · see citing works
van Bon, A. C., Bode, B. W., Sert-Langeron, C., DeVries, J. H., & Charpentier, G. (2011) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2010.0224 · Cited by 96 · see citing works
Pfützner, A., Sachsenheimer, D., Grenningloh, M., Heschel, M., Walther-Johannesen, L., Gharabli, R., & Klonoff, D. (2015) · Journal of Diabetes Science and Technology · doi:10.1177/1932296815604438 · Cited by 53 · see citing works
Insulin Pump Occlusions: For Patients Who Have Been Around the (Infusion) Block
Klonoff, D. C., Freckmann, G., & Heinemann, L. (2017) · Journal of Diabetes Science and Technology · doi:10.1177/1932296817700545 · Cited by 41 · see citing works
- Authors
- Hoogma, R., & Schumicki, D.
- Affiliations
- Groene Hart Ziekenhuis (NL)
- Venue
- Hormone and Metabolic Research
- Publisher
- Georg Thieme Verlag KG
- Published
- 2006-06
- Volume
- 38
- Issue
- 6
- Pages
- 429-433
- ISSN
- 0018-5043 (ISSN-L)
- 1439-4286
- OpenAlex
- W2106582738
- Cited by
- 66
- References
- 1
- Citations by year
- 2022: 2 · 2021: 2 · 2019: 1 · 2018: 5 · 2017: 2 · 2016: 1 · 2015: 3 · 2014: 4 · 2013: 2 · 2012: 4
- FWCI
- 6.33
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Hormone and Metabolic Research (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Keywords
- insulin glulisine, insulin pump therapy, type 1 diabetes, insulin aspart, drug safety, catheter occlusion, infusion site reactions, hypoglycemia, diabetic ketoacidosis, HbA1c
- MeSH terms
- Adult, Catheters, Indwelling, Diabetes Mellitus, Type 1, Drug Administration Routes, Equipment Failure, Female, Humans, Hyperglycemia, Hypoglycemia, Infusion Pumps, Insulin, Insulin Infusion Systems, Male, Middle Aged, Insulin Aspart
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