Pilot Study for Assessment of Optimal Frequency for Changing Catheters in Insulin Pump Therapy—Trouble Starts on Day 3

Schmid, Volkmar; Hohberg, C.; Borchert, Margret; Forst, Thomas; Pfützner, Andreas

doi:10.1177/193229681000400429

Cited by 84 publications

(92 citation statements)

References 20 publications

(24 reference statements)

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“…There was no single specific event related to an extended catheter use but events of all kinds and nature occurred after day 3, including but not limited to pulling out, kinking, adhesive getting loose, leakage of insulin from the infusion set or the infusion site, and signals of skin irritation, such as bruising, redness, or swelling. Even when the patients locally tolerated a longer use of the infusion sets at the infusion site for up to 7 days, there appeared to be changes in the insulin absorption leading to a slow but steady loss in glycemic control with increased duration of use, as indicated by a steady increase in mean daily blood glucose concentrations, which is in line with a most recent observational study by Perrin et al 11,12 In general, potential problems that may occur in adult and adolescent patients when using the infusion sets longer than the recommended 48-72 hours may be technical problems, such as catheter occlusions or kinking, 13,14 bacterial contaminations leading to skin inflammation, [15][16][17] potential changes in physicochemical delivery characteristics, 18,19 and local skin reactions to the adhesive, resulting in redness, itching, and other symptoms of skin irritation. 12 The purpose of this study was to evaluate the safety and efficacy of using infusion sets for 2 days versus 4 days during a period of 3 months each in a prospective and randomized crossover protocol in patients with type 1 diabetes.…”

supporting

confidence: 85%

“…22 As mentioned in the introduction, it has been observed that longer use of insulin pump catheters may result in impairment of glycemic control. 11,12 In our study HbA1c was improved with slightly less prandial insulin requirements during 2-day use, while no such effect was seen during 4-day use. It can be stated that all current and past limited evidence votes for keeping and reinforcing the usage time for insulin pump infusion sets to be no longer than 3 days.…”

Section: Discussioncontrasting

confidence: 40%

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Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events

Pfützner¹,

Sachsenheimer²,

Grenningloh

et al. 2015

J Diabetes Sci Technol

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Background: Infusion sets for use with insulin pumps are recommended for use for 2 to 3 days to avoid local skin reactions, for example, to the insulin formulation and preservatives like meta-cresol. However, many patients use the catheters longer for economic reasons. We performed this study to investigate the tolerability of 2-day use of infusion sets in comparison to 4-day use in a real-world setting. Methods: This prospective randomized controlled crossover study with 2 × 3-month observation periods was performed with 24 type 1 patients. At baseline, patients were trained on the use of the infusion system (Medtronic /Mio® or inset™ II) and randomized to any of the 2 treatment sequences. Observation parameters included glycemic control, frequency and nature of device-related, and procedure-related adverse events and patient preference. Results: The per-protocol analysis was performed with 22 patients (5 men, 17 women, age 39 ± 11 years, BMI 27.0 ± 3.5 kg/m2). The number of catheter related adverse events was 290 with 2-day use versus 495 with 4-day use ( P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day use ( P < .001). There was no difference in glycemic control between the treatment arms. Treatment satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < .05). Conclusion: Our results demonstrate that using the infusion sets for a longer usage period of 2-3 days resulted in a clinically relevant increase in treatment-related tolerability problems. Patients should be trained and encouraged not to use insulin pump infusion sets for a longer than the recommended time period.

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supporting

confidence: 85%

Section: Discussioncontrasting

confidence: 40%

Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events

Pfützner¹,

Sachsenheimer²,

Grenningloh

et al. 2015

J Diabetes Sci Technol

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“…7 An important observation from this study was that the PD responses to lispro and aspart were virtually identical both on day 1 and on day 4. While a small-scale study reported insulin infusion site adverse events on the third day of catheter use, 8 the age of the infusion catheter site had a significant accelerator effect on the PD profiles of both insulins in our study. 7 Compared to newer infusion sites (day 1), insulin PD responses using the older sites (day 4) were characterized by an earlier and greater peak insulin effect, as well as a shorter duration of insulin action.…”

Section: Advances In Insulin Therapy: Introduction Of Rapid-acting Incontrasting

confidence: 58%

Undeniable Need for Ultrafast-Acting Insulin: The Pediatric Perspective

Cengiz

2012

J Diabetes Sci Technol

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Insulin therapy in youth with type 1 diabetes mellitus (T1DM) poses a special challenge because childhood is an unsteady state with increasing weight, height, and caloric needs, leading to varying insulin requirements. The current rapid-acting insulin analogs are not as fast and short-acting as needed to meet these challenges. This review describes the unique characteristics of insulin action in youth with T1DM based on previously published euglycemic clamp studies. It also explains the rationale behind the need for ultrafast-acting insulins to advance open-and closed-loop insulin therapy for the pediatric population with diabetes. Lastly, it briefly summarizes ongoing and future projects to accelerate insulin action in youth with T1DM.

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“…4 In another study of 12 subjects asked to wear a Teflon catheter for up to 5 days, the authors reported that the mean daily glucose levels increased from a mean of 135 -68 mg/dL on Day 1 to 162 -72 mg/dL on Day 5 (P = difference not significant). 16 We did not see this increase in glucose levels or insulin requirements during the 25 weeks that subjects wore an infusion set for 7 days. Our interpretation of the difference between their study results and ours is that some of their subjects were experiencing infusion site failure, whereas in our study these subjects were excluded when we analyzed those who wore an infusion set successfully for 7 days.…”

Section: Figmentioning

confidence: 82%

Randomized Trial of Infusion Set Function: Steel Versus Teflon

Patel

Benasi²,

Ferrari³

et al. 2014

Diabetes Technology & Therapeutics

100

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Background: This study compared infusion set function for up to 1 week using either a Teflon Ò (Dupont Ô , Wilmington, DE) catheter or a steel catheter for insulin pump therapy in type 1 diabetes mellitus. Subjects and Methods: Twenty subjects participating in a randomized, open-labeled, crossover study were asked to wear two Quick-Set Ò and two Sure-T Ò infusion sets (both from Medtronic Minimed, Northridge, CA) until the infusion set failed or was worn for 1 week. All subjects wore a MiniMed continuous glucose monitoring system for the duration of the study. Results: One subject withdrew from the study. There were 38 weeks of Sure-T wear and 39 weeks of Quick-Set wear with no difference in the survival curves of the infusion sets. There was, however, a 15% initial failure rate with the Teflon infusion set. After 7 days, both types of infusion sets had a 64% failure rate. Overall, 30% failed because of hyperglycemia and a failed correction dose, 13% were removed for pain, 10% were pulled out by accident, 10% had erythema and/or induration of > 10 mm, 5% fell out because of loss of adhesion, and 4% were removed for infection. The main predictor of length of wear was the individual subject. There was no increase in hyperglycemia or daily insulin requirements when an infusion set was successfully used for 7 days (n = 25 of 77 weeks). Conclusions: We found no difference between steel and Teflon infusion sets in their function over 7 days, although 15% of Teflon sets failed because of kinking on insertion. The strongest predictor of prolonged 7-day infusion set function was the individual subject, not the type of infusion set.

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Pilot Study for Assessment of Optimal Frequency for Changing Catheters in Insulin Pump Therapy—Trouble Starts on Day 3

Cited by 84 publications

References 20 publications

Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events

Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events

Undeniable Need for Ultrafast-Acting Insulin: The Pediatric Perspective

Randomized Trial of Infusion Set Function: Steel Versus Teflon

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