Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes
Open accessAbstract
Background Improved insulin infusion set survival and faster insulin action are important issues for pump users and for the development of an artificial pancreas. The current recommendation is to change infusion sets every 3 days. Our objectives were to determine the effect of lipohypertrophy (LH) on infusion set survival and continuous glucose monitoring glucose levels. Research design and methods In this multicenter crossover trial, we recruited 20 subjects (age 28.1 ± 9.0 years) with type 1 diabetes (duration 17.5 ± 8.8 years) and an area of lipohypertrophied tissue >3 cm. Subjects alternated weekly wearing a Teflon infusion set in an area of either LH or non-LH for 4 weeks. Sets were changed after (a) failure or (b) surviving 7 days of use. Results The least-squares mean duration of infusion set survival for sets that lasted 0.38 on each day). Conclusion LH did not significantly affect infusion set survival or mean glucose. Achieving optimal infusion set performance requires research into factors affecting set survival. Additionally, the recommendation for duration of set change may need to be individualized.
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Some patients successfully wear CSII catheters up to 7 days.
“Studies have shown that some patients indeed successfully wear CSII catheters up to 7 days.19,24”
From Detailed Analysis of Insulin Absorption Variability and the Tissue Response to Continuous Subcutaneous Insulin Infusion Catheter Implantation in Swine (2017) · cites this paper as [24]
The EIS failure rate due to unexplained hyperglycemia or both unexplained hyperglycemia and device-related SevHyper was substantially lower than the 19%, 23%, 30%, and 35% reported to be attributable or partly attributable to unexplained hyperglycemia in studies investigating extended standard IIS wear.
“The EIS failure rate due to unexplained hyperglycemia or both unexplained hyperglycemia and device-related SevHyper was quite low (≤2%) and substantially lower than the 19%,9 23%,18 30%,8 and 35%18 reported to be attributable or partly attributable to unexplained hyperglycemia in the studies investigating extended standard IIS wear.”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [18]
While early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.
“Thus, while early standard IIS device studies confirmed manufacturer indications for 2- to 3-day use due to increased risk of IIS site reactions or compromised glycemic control, more recent studies with greater numbers of study participants have reported minimal or no issues with glycemia over time or fewer adverse events associated with extended IIS wear.8,9,18,19”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [18]
The overall EIS survival rate by the end of day 7 was greater than previously reported survival rates for standard IIS devices worn for similar durations (69%, 63%, 43%, 33%, and 32%).
“The overall EIS survival rate of 77.8% (95% CI: 76.2–79.3) by the end of day 7 was greater than previously reported survival rates of 69% (n = 40 total participants and 80 total steel cannula sets),9 63% (n = 40 total participants, 80 total soft cannula sets),9 43% (n = 20 total participants, 40 total sets in non-lipohypertrophied tissue),18 33% (n = 20 total participants and 40 total sets in lipo”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [18]
There were multiple definitions of a failed correction dose, with 1 h or 60-90 min as the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.
“There were also multiple definitions of a failed correction dose where 1 h8,18 or 60–90 min9 was the elapsed time by when a single correction dose was required to decrease BG by 50 mg/dL.”
From Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial (2022) · cites this paper as [18]
The observed infusion set duration is comparable to infusion set durations observed in previous studies.
“The observed infusion set duration is comparable to infusion set durations observed in previous studies. 15,29”
From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [15]
SFs may be caused by catheter kinking, insulin precipitation, insulin leakage, site inflammation, set detachment, or otherwise unknown reasons and lead to hyperglycemia and ketonemia if left uncorrected.
“SFs may be caused by catheter kinking, insulin precipitation, insulin leakage, site inflammation, set detachment, or otherwise unknown reasons and lead to hyperglycemia and ketonemia if left uncorrected.”
From Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas (2018) · cites this paper as [15]
Cites
Regression analysis of multivariate incomplete failure time data by modeling marginal distributions
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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
Randomized Trial of Infusion Set Function: Steel Versus Teflon
Patel, P. J., Benasi, K., Ferrari, G., Evans, M. G., Shanmugham, S., Wilson, D. M., & Buckingham, B. A. (2014) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2013.0119 · Cited by 90 · see citing works
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Hauzenberger, J. R., Hipszer, B. R., Loeum, C., McCue, P. A., DeStefano, M., Torjman, M. C., Kaner, M. T., Dinesen, A. R., Chervoneva, I., Pieber, T. R., et al. (2017) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2017.0175 · Cited by 39 · see citing works
“Studies have shown that some patients indeed successfully wear CSII catheters up to 7 days.(19,24) In contrast, the ICs produced the highest AUC, AUC60, and Cmax on day 1, the fastest tmax on day 3, and the lowest AUC, AUC60, and Cmax on day 5.”
BackgroundReal-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas
Howsmon, D. P., Baysal, N., Buckingham, B. A., Forlenza, G. P., Ly, T. T., Maahs, D. M., Marcal, T., Towers, L., Mauritzen, E., Deshpande, S., et al. (2018) · Journal of Diabetes Science and Technology · doi:10.1177/1932296818755173 · Cited by 32 · see citing works
Self-citationBrazg, R., Garg, S. K., Bhargava, A., Thrasher, J. R., Latif, K., Bode, B. W., Bailey, T. S., Horowitz, B. S., Cavale, A., Kudva, Y. C., et al. (2022) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2021.0540 · Cited by 28 · see citing works
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- Authors
- Karlin, A. W., Ly, T. T., Pyle, L., Forlenza, G. P., Messer, L., Wadwa, R. P., DeSalvo, D. J., Payne, S. L., Hanes, S., Clinton, P., Maahs, D. M., & Buckingham, B.
- Affiliations
- Georgetown University (US)
- The University of Western Australia (AU)
- Colorado School of Public Health (US)
- University of Colorado Health (US)
- Baylor College of Medicine (US)
- Stanford Medicine (US)
- Corresponding author
- Maahs, David M.
- ORCID
- Venue
- Diabetes Technology & Therapeutics
- Publisher
- SAGE Publications
- Published
- 2016-07
- Volume
- 18
- Issue
- 7
- Pages
- 429-435
- ISSN
- 1520-9156 (ISSN-L)
- 1557-8593
- PMC
- PMC4931738
- OpenAlex
- W2406035951
- Cited by
- 32
- References
- 3
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 2 · 2023: 3 · 2022: 7 · 2021: 4 · 2020: 3 · 2019: 1 · 2018: 4 · 2017: 5 · 2016: 1
- FWCI
- 3.69
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Diabetes Technology & Therapeutics (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001085)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Physical Sciences › Engineering › Biomedical Engineering › Intravenous Infusion Technology and Safety
- Health Sciences › Medicine › Dermatology › Skin Diseases and Diabetes
- Keywords
- lipohypertrophy, type 1 diabetes, continuous glucose monitoring, insulin infusion, insulin pump therapy, hyperglycemia, artificial pancreas
- MeSH terms
- Adipose Tissue, Adolescent, Adult, Blood Glucose, Child, Diabetes Mellitus, Type 1, Equipment Failure, Female, Humans, Hyperglycemia, Hypertrophy, Insulin Infusion Systems, Male, Middle Aged, Cross-Over Studies, Young Adult
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