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
Maintaining good glycaemic control with the same infusion set for longer than 3 days may improve the quality of life of insulin pump users. The aim of the current study was to assess the efficacy and safety of the novel, extended‐wear infusion set over 7 days of wear in adults with type 1 diabetes. Sixteen participants completed three identical 8‐hour euglycaemic clamp experiments on Days 1, 4 and 7 of infusion set wear. Between the experiments, the participants were discharged home for routine diabetes management while wearing the same extended‐wear infusion set throughout the study. Time to reach the maximum glucose infusion rate (TGIRmax) on Day 7 was reduced by 67% compared with Day 1 (p < .001). The corresponding area under the glucose infusion rate curve (AUCGIR) was comparable for the first 2 h of the clamp (p = .891) but decreased by 28% over time (p < .008). While the extent of insulin absorption decreased with prolonged wear, it was accompanied by an increase in insulin absorption rate. The infusion set survival rate was 100% without leakages, occlusion alarms, severe hypoglycaemia or ketoacidosis. The extended‐wear infusion set proved safe and effective during prolonged wear in real‐life conditions.
Objective: Current insulin infusion sets are approved for 2-3 days of wear; however, glucose sensors are approved for 7-14 days of wear. A commonly reported reason for discontinuing use of CGM within 1 year is not wanting to wear devices on two sites of the body. Any attempt to create a combined glucose sensor and infusion set for closed-loop control requires a set with greater longevity. The coated ConvaTec Infusion Set with Lantern Technology is a new infusion set with multiple slits and coating intended to reduce foreign body response and occlusion from bending or kinking. Methods: A pilot safety and extended wear tolerability study is being performed at Stanford University. To date, 15 adult subjects on tethered insulin pump therapy using insulin aspart or lispro have completed the study. Each participant places the set and wears it for 10 days or until set failure to establish a maximum length of infusion set wear when 80% of sets are still functional (excluding accidental “pull-outs”). Infusion set failures are based on: (1) Presence of serum ketones with hyperglycemia; (2) Unexplained hyperglycemia, unresolved with correction dose; (3) Signs of infection at the infusion site; (4) Pump occlusion alarm; and (5) Adhesive failure. Results: Two subjects did not meet failure criteria and were excluded. Of the remaining, 6 (46%) wore the novel infusion set the full 10 days and all sets lasted 7 days or more (mean 8.8 days). 3 premature set failures were associated with persistent hyperglycemia unresponsive to correction boluses on days 7-8, 3 with adhesive failure on days 7-9, and 1 with infection on day 9. Conclusions: In our previous studies assessing 353 infusion set insertions for 7 days, average length of wear was 5.1 ± 1.7 days. Thus far, the novel set has demonstrated increased longevity. The duration of wear established in this pilot study will be used to perform a masked, randomized controlled crossover study comparing the coated ConvaTec Infusion Set with Lantern Technology against standard infusion sets. Disclosure R. Lal: Consultant; Self; Abbott. P.K. Schøndorff: Employee; Self; ConvaTec Inc. L. Hsu: None. M. Heschel: Employee; Self; Unomedical a/s. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care.
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