Longevity of the novel ConvaTec infusion set with Lantern technology

Abstract

Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time.The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.CSII, insulin pump therapy, insulin therapy, type 1 diabetes | INTRODUCTIONThe weak link in insulin pump and closed-loop therapy is the insulin infusion set that is inserted under the skin. There is limited information on the interaction between the infusion set, subcutaneous tissue and insulin. The infusion set can become occluded or kinked, and local inflammation and infection around the site can result in insufficient insulin delivery, high glucose levels, ketoacidosis and death. 1,2 There are few studies [3][4][5][6][7] published on the extended use of infusion sets beyond 3 days, although investigation is in progress by Capillary Biomedical (NCT04398030) and Medtronic (NCT04113694). Past studies have tested infusion sets for up to 7 days: Patel et al. reported a median wear time of 6.06 (4.35, 6.98) days, 5 Karlin et al. a least squares mean wear time of 4.12-4.31 days, 6 and Waldenmaier et al. a mean wear time of 6.2 ± 1.5 days. 7 The study conducted by Patel et al. established failure criteria for infusion sets and was a randomized, open-label, crossover study of 20 subjects who wore Teflon catheter (Quick-Set) and steel catheter (Sure-T) infusions set for up to 1 week with no difference in the survival curves of the infusion sets.Length of wear of any infusion set was subject specific, and 30% of failures were secondary to uncorrectable hyperglycaemia, indicating partial catheter occlusion or limitations on insulin absorption in the subcutaneous space. 5 The Karlin study was a multicentre, crossover trial that showed no difference in infusion set survival or mean glucose in 20 individuals with type 1 diabetes wearing the sets in lipohypertrophied and non-lipohypertrophied tissue.Our hypothesis was that the ConvaTec infusion set with Lantern technology, a novel infusion set (Figure 1) with additional slitted

Feasibility study of a prototype extended‐wear insulin infusion set in adults with type 1 diabetes

“…In conjunction with the fall in TIR, there was a reciprocal increase in time in hyperglycaemia suggesting a deterioration in glucose control when the set is worn beyond 72 h. In keeping with the aforementioned, TDD of insulin also increased with time. The increase in glucose levels with duration of IIS wear reflect the observations described in reports of other extended‐wear infusion set studies 11,12 …”

“…Other people report a worsening of glycaemic control over time, prompting them to change their IIS before the recommended 3‐day period 6,8,10 . Recently published data formally evaluating improved extended‐wear IISs have shown up to 7 days of wear time with reduced failures and increased patient satisfaction although some have reported an increase in average glucose per day of infusion set wear 11–15 . We suggest that there is room and a need for improvement in current IIS technology to increase the reliability of insulin delivery, reduce patient burden and minimize waste.…”

“…The increase in glucose levels with duration of IIS wear reflect the observations described in reports of other extended-wear infusion set studies. 11,12 The ability to maintain the integrity of subcutaneous insulin delivery over extended periods may be compromised by several factors.…”

“…7 days of wear time with reduced failures and increased patient satisfaction although some have reported an increase in average glucose per day of infusion set wear. [11][12][13][14][15] We suggest that there is room and a need for improvement in current IIS technology to increase the reliability of insulin delivery, reduce patient burden and minimize waste.…”

Barriers to Uptake of Insulin Technologies and Novel Solutions

“…Preliminary research by ConvaTec, Medtronic, and Capillary Biomedical, among others, is showing the potential for infusion sets to function for 7–10 days. 120 The ConvaTec study published by Lal demonstrated a median wear time of 9.1 days. Such progress has the potential to limit set changes to a once-a-week occurrence, further reducing the burden of pump and AID system use.…”