Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology
Phase: NA
Conditions: Insulin Dependent Diabetes Mellitus 1
Sponsor: Stanford University

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Longevity of Multi-Slitted Catheter,  
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the Convatec Inset II with Lantern Technology  
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Version 2.1 
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6/21/2018 
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NCT 03819634 
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Table of Contents 
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CHAPTER 1: Introduction ............................................................................................. 4 
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Study Objective............................................................................................................ 4 
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Background and Rationale .......................................................................................... 4 
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Etiology of Infusion Set Failures .................................................................................. 5 
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Preliminary Data .......................................................................................................... 6 
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Protocol Synopsis ........................................................................................................ 7 
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Part 1: Pilot Safety and Extended Wear Tolerability Study................................................................... 7 
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Part 2: Extended Wear Randomized Controlled Crossover Study ........................................................ 8 
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General Considerations ............................................................................................... 9 
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CHAPTER 2: Subject Enrollment and Study Initiation ............................................. 10 
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Study Enrollment and Duration .................................................................................. 10 
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Eligibility Criteria ........................................................................................................ 10 
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Exclusion Criteria ....................................................................................................... 10 
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Recruitment Plan ....................................................................................................... 11 
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Informed Consent Plan and HIPAA Authorization ..................................................... 11 
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Eligibility Assessment and Baseline Data Collection ................................................. 11 
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Authorization Procedures .......................................................................................... 12 
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CHAPTER 3: Protocol Procedures ............................................................................. 13 
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Part 1: Pilot Safety and Extended Wear Tolerability Study ........................................ 13 
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First Visit .............................................................................................................................................. 13 
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Home Monitoring ................................................................................................................................ 13 
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Final Visit ............................................................................................................................................. 14 
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Part 2: Extended Wear Randomized Controlled Crossover Study ............................. 14 
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First Visit .............................................................................................................................................. 14 
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Home Monitoring ................................................................................................................................ 15 
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Final Visit ............................................................................................................................................. 16 
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CHAPTER 4: Adverse Event Reporting and Protocol Monitoring ........................... 17 
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Definition .................................................................................................................... 17 
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Recording of Adverse Events .................................................................................... 17 
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Reporting Serious or Unexpected Adverse Events .................................................... 18 
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Potential Risks and Side Effects ................................................................................ 19 
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Local Reaction ..................................................................................................................................... 19 
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Invasive Testing ................................................................................................................................... 19 
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Hypoglycemia ...................................................................................................................................... 19 
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Hyperglycemia .................................................................................................................................... 19 
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Protection against Risks and Treatment of Side Effects ............................................ 19 
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Other Risks ................................................................................................................ 20 
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CHAPTER 5: Miscellaneous Considerations ............................................................ 21 
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Potential Benefits ....................................................................................................... 21 
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Subject Compensation ............................................................................................... 21 
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Subject Withdrawal .................................................................................................... 21 
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Subject Discontinuation Criteria ................................................................................. 21 
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Confidentiality ............................................................................................................ 22 
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Level of Risk .............................................................................................................. 22 
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Planned Duration of the Entire Study ......................................................................... 22 
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CHAPTER 6: Statistical Considerations .................................................................... 23 
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Part 1 ......................................................................................................................... 23 
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Part 2 ......................................................................................................................... 23 
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Primary Outcome ................................................................................................................................ 23 
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Exploratory Outcomes ........................................................................................................................ 23 
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CHAPTER 7: References ............................................................................................ 24 
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CHAPTER 1: Introduction 
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Study Objective 
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To determine if the Convatec Inset II with Lantern technology (Convatec Lantern) 
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infusion set with multi-slitted catheter, will have a longer time to failure than a previous 
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infusion set without side ports, the Inset II/Mio. 
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Background and Rationale 
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The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive glucose 
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control delays the onset and slows the progression of retinopathy, nephropathy, neuropathy 
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and cardiovascular disease for people with type 1 diabetes [1-2].  Multiple trials have shown 
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improvements in glycemic control and a lower incidence of hypoglycemia in adults and 
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children with diabetes who use insulin pump therapy [3-6].  The weak link in pump therapy 
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is the infusion set that is inserted under the skin.  It can become occluded or kinked and 
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local inflammation and infection around the site can result in insufficient insulin delivery and 
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high glucose levels which can lead to diabetic ketoacidosis [7].   
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Current infusion sets are approved for 2-3 days of wear [8-10], however, sensors are 
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approved for 10 days of wear with greatest accuracy after the first day [11].  Thus, any 
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attempt to create a combined sensor and insulin infusion set requires an infusion set 
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with greater longevity.  With the advent of closed-loop control, patients are required to 
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wear both a sensor and insulin infusion set [12].  Out of 1006 people wearing a CGM, 
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27% discontinued CGM use after one year and 33% said this was because they did not 
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want to have devices on two sites of their body [13-14].  Finding multiple, comfortable 
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sites can be particularly challenging with younger children who have a smaller body 
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surface area.  Two groups have attempted to combine a sensor and infusion set into 
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one device but it was not practical due to limited infusion set longevity [15-16]. 
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When the sensor is in one location and the infusion set is in another, it means two 
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separate insertions for the patient, and frequent reapplication of adhesive tapes to keep 
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both devices in place.  When the adhesive tape is removed a layer of epidermis is also 
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removed, which is one of the natural barriers to infections.  When subjects are wearing 
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multiple devices with multiple adhesives there is also an increased risk for adhesive 
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tape allergies (Figure 1).  There would be a significant benefit to combining an insulin 
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infusion set with a continuous glucose sensor if they both could be worn for 7-10 days. 
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Figure 1.  Children wearing sensor and infusion set with limited subcutaneous sites, leading to 
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overcrowding and skin reactions 
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There are very few studies published on extended use of infusion sets beyond three 
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days.   Bode and colleagues studied the safety and efficacy of Novolog insulin in 19 
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subjects used the same infusion set tubing for 7 days and overall, no negative effects 
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on glycemic control were observed during this period but it was noted that serum 
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glucose levels began to increase the longer the infusion set was used [17].  There have 
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been three published randomized trials assessing length of infusion set wear beyond 3 
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days. One study compared using insulin lispro to insulin aspart for 5 days of infusion set 
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wear [18]. There was no difference between the two insulins, with an average length of 
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infusion set wear of 98 and 96 hours, respectively. The researchers reported increased 
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glucose levels after 48 hours of wearing an infusion set and recommended changing 
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infusion sets every 2 days.  We conducted a randomized, open-label, crossover study of 
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20 subjects who wore Teflon catheter (Quick-Set) and steel catheter (Sure-T) infusions 
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set for 38 weeks and 39 weeks respectively with no difference in the survival curves of 
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the infusion sets.  The mean duration of wear was 5.5 days with a standard deviation of 
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1.9 days.  Intersubject variation and the majority of failures were secondary to 
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uncorrectable hyperglycemia which indicates insulin flow occlusions [19].  Another 
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multicenter, crossover trial showed no difference in infusion set survival or mean 
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glucose in 20 type 1 diabetes subjects wearing the sets in either lipohypertrophied and 
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nonlipohypertrophied tissue [20].   
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Etiology of Infusion Set Failures 
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The underlying cause of intersubject variation in infusion set wear time is unknown but 
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in the prior infusion set studies time to failure was primarily associated with 
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hyperglycemia which did not improve with correction dose of insulin.  In most of these 
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subjects, there was no overt back-pressure error from the pump.  “Silent occlusions” 
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would be the most likely causative factor, and the additional slitted openings would 
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reduce the risk of silent occlusions and subsequent hyperglycemia (Figure 2).  The 
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Lantern is designed to reduce failures due to kinking.  Other less common causes for 
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set failure would probably not be affected by the Lantern; these include 10-15% being 
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pulled out by accident (tubing caught on a door handle for example), 6-12% from loss of 
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adhesiveness, 5-13% removed for pain and 5-10% for erythema/induration concerning 
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for infection.  Approximately 30% of subjects reporting erythema/induration also 
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reported pain [19-20, unpublished data].  In addition, this will be the first infusion set 
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study to assess attitudes towards diabetes technology, which could also correlate with 
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time to failure and explain some of the intersubject variability.   
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Figure 2.  Lantern catheter being kinked by underlying muscle, but insulin continues to be delivered 
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through side openings. 
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Preliminary Data 
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The single use infusion set is similar to the already CE approved Inset II infusion set 
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with the addition of below features, and consists of an insertion device with introducer 
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needle that inserts the soft cannula into the skin. The intervention infusion set presents 
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a hydrophilic coated soft cannula with Lantern Technology – 6 slits (Figure 3). 
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Figure 3.  Lantern catheter (left) demonstration of increased surface area (middle) and µCT 
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reconstruction of insulin delivery from an occluded catheter in human skin explant (right). 
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Materials in fluid paths has been tested with insulin lispro, aspart, glulisine and regular 
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human insulin.  A swine study conducted at the Medical University of Graz compared 
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the immune response to insulin infusion systems of different materials over a course of 
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7 days of wear time in 10 female farm swine. The manufacturer analyzed the 
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inflammatory response to 2 commercially available catheters (Teflon and steel) and 3 
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Teflon prototypes that were implanted into the subcutaneous adipose tissue for 1 day, 4 
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days and 7 days. Two of the three prototypes were coated with passive coatings, which 
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suppress the inflammatory response without releasing an anti-inflammatory agent. The 
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third prototype was a new all-in-one catheter design (blinded for investigator) that did 
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not require a separate inserter. The impact of an anti-inflammatory passive coatings on 
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the foreign body response was evaluated. All catheters were tested for a wear time of 1 
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day, 4 days and 7 days. Tissue was explanted and immune cells and connective tissue 
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were stained using standard histopathological methods. This study indicated potential 
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beneficial effects of passive anti-inflammatory coatings for insulin infusion catheters.  
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Another study conducted at the Joanneum Research Institute, Graz assessed the 
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insulin distribution in subcutaneous adipose tissue when using infusion set with Lantern 
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Technology. The infusion set was inserted into fresh human adipose tissue explants 
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with the aim to investigate the effect of catheter designs on the formation of 
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subcutaneous insulin depots. The study showed that the full functionality of the novel 
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insulin catheter is guaranteed independent of whether the catheter is open, kinked or 
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distally occluded. Therefore, it is not necessary to replace a kinked catheter or a 
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catheter with a clogged tip from the viewpoint of proper insulin delivery, which reduces 
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the incidence of unexplained hyperglycemia and even ketoacidosis which can be 
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associated with infusion set failures, as well as decreasing the discomfort for patients of 
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inserting multiple infusion catheters as a result of early failure. Study investigators 
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concluded that the new infusion catheter can provide a valuable contribution to patients’ 
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well-being and safety. 
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In data that will be presented at the American Diabetes Association 2018 meeting, 
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glucose clamp studies were conducted in Graz among 16 patients with type 1 diabetes 
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(age 44.2 ± 15.4 years, BMI 24.5 ± 2.3 kg/m2, HbA1c 55 ± 8 mmol/mol, diabetes 
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duration 20 ± 9 years) with type 1 diabetes.  All 16 patients wore the set for 7 days 
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without severe hypoglycemia or diabetic ketoacidosis.  Geometric means of maximum 
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glucose infusion rates were comparable for days 1, 4 and 7.  This preliminary data 
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strongly supports the safety of this infusion set and the need for real world testing of 
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longevity. 
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Protocol Synopsis 
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Part 1: Pilot Safety and Extended Wear Tolerability Study 
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This is a pilot study to obtain preliminary data upon which to base the length of wear for 
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the second part of the study. The study is not intended for registration purposes or to 
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support a 510(k) submission. The study will be conducted at one site: Stanford 
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University. 
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This study will enroll 24 subjects to establish the maximum length of Lantern infusion 
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set wear when 80% of sets are still functional (excluding accidental “pull-outs”).  We will 
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plan for a staged enrollment, the first 10 subjects will be 18 or older.  If there are no 
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untoward effects we will begin enrolling participants age 15-18.  Each participant will 
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place the set and wear it for 10 days or until set failure and data will be collected on the 
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cause of set failure.  If a set is accidentally pulled out, it can be replaced by the subject.  
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Subjects will either complete a daily online questionnaire or they will be contacted daily 
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by research staff to determine if a set has failed, the cause of failure, and to record 
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measured erythema and edema at a failed infusion site.  Failures are based on: 
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1. Presence of serum ketones with hyperglycemia 
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2. Unexplained hyperglycemia 
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3. Signs of infection at the infusion site 
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4. Pump occlusion alarm 
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5. Adhesive failure 
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Since infusion set failures will occur after variable lengths of wear, regularly scheduled 
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visits are unlikely to capture the day of an infusion set failure.  Instead the subject will be 
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taught how to insert the set, measure erythema and induration with a ruler marked in 
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millimeters and to take a picture of the infusion site.  Subjects will be instructed to text 
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the study team when they remove their infusion set and to send a picture of the infusion 
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site and measurements.  If there is any evidence of an infection (≥10 mm of erythema or 
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induration), they will be asked to come in that day for an unscheduled visit. 
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Part 2: Extended Wear Randomized Controlled Crossover Study 
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This will be a masked, randomized controlled crossover study at Stanford University 
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(Figure 4).  The study is intended for registration purposes and to support a 510(k) 
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submission. The planned duration of wear and visit schedule will be determined by the 
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results of Part 1.  Participants, age 15 and over, will be randomized to wear the masked 
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investigational or control infusion set first. The control set is the Mio (used with 
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Medtronic pumps) or Inset II (used with other pump models) which are the precursors to 
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the Convatec Lantern and do not contain slits.  Each participant with wear both the 
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investigational and control infusion set. Subjects will act as their own control.   
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At home subjects will examine their infusion site when they are changing an infusion set 
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and assess for signs of bleeding, local tissue reaction or infection.  They will record 
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redness, induration, and bruising in mm, and call one of the investigators if there is 
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more than 10 mm of erythema or induration.  They will be given a ruler for making these 
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measurements. If there is more than 3 mm of induration or redness they will be asked to 
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take a picture and enter these measurements and send a text to the study coordinator.   
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They will be instructed to replace the infusion set for: 
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1. Presence of serum ketones with hyperglycemia 
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2. Unexplained hyperglycemia 
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3. Signs of infection at the infusion site 
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4. Pump occlusion alarm 
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5. Adhesive failure 
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Figure 4. Study Diagram 
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General Considerations 
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The study is being conducted in compliance with the policies described in the study 
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policies document, with the ethical principles that have their origin in the Declaration of 
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Helsinki, with the protocol described herein, and with the standards of Good Clinical 
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Practice. 
 
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Visit 1 
Consent 
and Randomize 
Wear 1 
Lantern 
Wear 2 
Inset II/Mio 
Wear 1 
Inset II/Mio 
Wrap-up Visit 
 
Wear 2 
Lantern 
Wrap-up Visit 
 
At study conclusion 
 
Data Collection 
Download CGM 
- Avg daily glucose data 
Download Pump 
Download Meter 
DSAT/DDS score 
Between Wears 
REDCap Survey or 
Phone Call/Text at time of set 
failure 
 
Time to Failure 
Cause of Failure 
Erythema/Induration (mm) 
Enrollment 
Study supplies provided 
 
Data Collection 
Age 
Gender (female, urine hCG) 
Race/Ethnicity 
Diabetes duration 
BMI 
HbA1c 
Insulin 
Avg Total Daily Insulin Dose 
Pump model / Download 
CGM model 
Glucometer model 
Infusion set questionnaire 
DSAT/DDS score 
At each wear 
Infusion set inserted by 
patient on new body area on 
wear 1 and contralateral 
location on wear 2. 
 
Used infusion sets will be 
saved and returned at study 
conclusion. 
 
Data Collection 
Location of set placement 

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CHAPTER 2: Subject Enrollment and Study Initiation 
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Study Enrollment and Duration 
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Part 1: 24 subjects – Maximum of 10 days of wearing a single Lantern infusion set. 
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Part 2: 40 subjects – Each subject will wear control (Inset II/Mio) and experimental 
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(Lantern) infusion set for the number of days determined from Part 1 
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Eligibility Criteria 
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To be eligible for the study, a subject must meet the following criteria: 
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1. Age 15 and over 
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2. On tethered insulin pump therapy with any rapid acting insulin, for at least 3 
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months 
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3. Hemoglobin A1c level less than or equal to 10% 
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4. Eating more than 60 grams of carbohydrate each day 
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5. For females, not currently known to be pregnant 
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6. Understanding and willingness to follow the protocol and sign informed consent 
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7. Willingness to wear the experimental infusion sets 
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8. Willingness to have photographs taken of their infusion sites  
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9. Ability to speak, read and write in the language of the investigators 
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Exclusion Criteria 
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The presence of any of the following is an exclusion for the study: 
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1. Diabetic ketoacidosis in the past 3 months 
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2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 
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months prior to enrollment  
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3. Pregnant or lactating  
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4. Known tape allergies  
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5. Active infection 
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6. A known medical condition that in the judgment of the investigator might interfere 
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with the completion of the protocol 
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7. Known cardiovascular events in the last 6 months 
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8. Known acute proliferative diabetic retinopathy 
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9. Known adrenal disorder 
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10. Current treatment for a seizure disorder 
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11. Inpatient psychiatric treatment in the past 6 months 
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12. Lack of stability on medication 1 month prior to enrollment including 
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antihypertensive, thyroid, anti-depressant or lipid lowering medication. 
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13. Use of SGLT inhibitor 
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14. Suspected drug or alcohol abuse 
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15. Dialysis or end stage kidney disease 
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Note: Adequately treated thyroid disease and celiac disease do not exclude subjects 
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from enrollment. 
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Recruitment Plan 
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We will contact subjects using our existing database of patients who have consented to 
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be contacted about future diabetes research studies.  A short description of the present 
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study will be given to them via email, phone or in-person. We will also recruit subjects at 
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the time of their scheduled appointments.  A one-page brochure will be prepared and 
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sent to providers who have referred patients to us in the past.  Information on the study 
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will also be posted on our website, and the information provided on the brochure will 
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also be made available to diabetes support groups in our area.  If a person expresses 
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interest, then the study will be presented in detail.  The study will be eligible to people 
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with type 1 diabetes who are not currently enrolled in other intervention studies.  
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Subjects participating in a registry study (no interventions) may participate.   
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Informed Consent Plan and HIPAA Authorization 
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The subject will be allowed sufficient time to read over the IRB approved consent form 
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and given opportunity to have all questions answered.  The consent will contain a brief 
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description of the research project, as well as the procedures and treatments to be 
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undertaken, and the risks of each treatment and procedure.  Consent form will be 
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obtained by delegated research staff. The PI and study staff will be available to fully 
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discuss consent with the subjects as needed.  Subjects have the right to withdraw at 
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any time during the study.  For eligible subjects, the study will be discussed with the 
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subject (and parent/legal guardian if the subject is a minor, referred to subsequently as 
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‘parent’).  The subject/parent will be provided with the Informed Consent Form to read 
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and will be given the opportunity to ask questions.  If the subject agrees to participate, 
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the Informed Consent Form will be signed.  A copy of the consent form will be provided 
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to the subject and another copy will be added to the subject’s clinic chart.    Written 
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informed consent must be obtained from the subject prior to performing any study-
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specific procedures that are not part of the subject’s routine care not part of the 
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subject’s routine care. 
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Eligibility Assessment and Baseline Data Collection 
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Potential subjects will be evaluated for study eligibility through the elicitation of a 
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medical history, performance of a physical examination by study personnel.  A history 
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will be elicited from the subject and additional information may be extracted from 
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available medical records.  The history will include the subject’s diabetes history, current 
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diabetes management including insulin pump download, other past and current medical 
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problems, past and current medications, and drug allergies.  A diabetes focused 
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physical exam (including vital signs and height and weight measurements) will be 
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performed by the study investigator or designee (an attending physician, fellow, nurse 
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practitioner or a physician assistant).  Particular attention will be given to insulin infusion 
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sites for chronic and acute skin and subcutaneous changes including reactions to 
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adhesives, lipohypertrophy, subcutaneous nodules and scarring.  Participants will 
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receive a questionnaire regarding experiences with infusion sets.  We will also perform 
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previously validated questionnaires, the “Diabetes-Specific Attitudes about Technology 
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Use” (DSAT) [21] and “Diabetes Distress Scale” (DDS) [22]. 
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HbA1c level will be measured using on site point-of-care testing.  HbA1c measurements 
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performed as part of usual clinical care within 2 weeks prior to obtaining informed 
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consent for participation in the trial may be used.  In female participants a urine 
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pregnancy test will be performed. 
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Authorization Procedures 
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As part of the informed consent process, each subject (and parent for minors) will be 
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asked to sign an authorization for release of personal information.  The investigator, or 
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his or her designee, will review what study specific information will be collected and to 
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whom that information will be disclosed.  After speaking with the subject (and parent for 
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minors), questions will be answered about the details regarding authorization. 
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CHAPTER 3: Protocol Procedures 
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Part 1: Pilot Safety and Extended Wear Tolerability Study 
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First Visit 
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Informed Consent Process: The protocol will be reviewed with the subjects, they will be 
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given time to read the informed consent and ask any questions about the study.  
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Demographic information for eligibility including age, gender, diabetes duration and 
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duration of pump use will be collected. 
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History and physical exam: Race/ethnicity will be recorded, as well as information about 
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diabetes care including diabetes duration, insulin (Aspart, Lispro, Fiasp or Glulisine), 
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average total daily insulin dose, carbohydrate consumption, pump model, CGM model, 
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glucometer model and infusion set questionnaire.  Physical exam will be performed 
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including vital signs, height, weight, BMI and examination of skin where infusion set, 
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and sensor will be inserted. 
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Laboratory Studies: Point-of-care hemoglobin A1c, and pregnancy test for all females.   
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Initiation visit and placement of infusion set: At the enrollment visit, subjects are 
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provided with study supplies that they do not already have, including Dexcom G6 CGM, 
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glucometer, and Precision Xtra ketone meters. Glucometers will be tested with control 
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solutions by study staff to ensure accuracy before being provided to patients.  Education 
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will be provided on the use of these devices.  Subjects will continue to use their 
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personal insulin pump and insulin as usual.  The patient’s insulin pump will be 
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downloaded.  Infusion sets will be placed in a suitable subcutaneous location without 
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lipohypertrophy by the patient.  If a set failure occurs prior to 10 days, they will return to 
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using their usual infusion set.  If a set fails within 24 hours of insertion, it will be replaced 
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and the second set worn up to 10 days.  As in the prior studies [19-20], participants will 
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be contacted by the study investigators to collect data regarding the site 
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(erythema/induration measured in millimeters) and set failure on a daily basis, either 
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through REDCap, a text message exchange, or a phone call.   
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Home Monitoring 
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Training on home procedures: Subjects will use Dexcom G6 according to manufacturer 
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labeling.  While the G6 system is FDA approved for non-adjunctive use without 
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calibration, we will ask patients to confirm their blood glucose with their study 
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glucometer prior to removing an infusion set.  Subjects will be instructed to check blood 
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ketones using a blood ketone meter if there is unexplained hyperglycemia.  Unexplained 
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hyperglycemia refers to high glucose levels outside of the usual times they may occur, 
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such as in the initial few hours following a meal. If the CGM stops functioning during the 
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study, the subjects will insert a new sensor which will be provided to them.  If there is an 
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accidental removal of an infusion set the participant will have access to a replacement 
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which he or she will be taught to place. 
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Determination of an infusion set failure: 
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They will be instructed to replace their infusion set, in the following situations. 
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1. The presence of serum ketones >0.6 mmol/L with meter glucose >250 mg/dL, in 
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the absence of illness, vigorous fat burning exercise, starvation or alcohol. 
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2. Unexplained hyperglycemia, >250mg/dL, outside anticipated periods of 
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carbohydrate consumption, illness, missed insulin doses and menstruation.  This 
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hyperglycemia cannot be reduced with appropriate correction doses of insulin 
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(such as a decrease of at least 50mg/dL in 1 hour following a correction dose). 
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3. Signs of infection at the infusion site including pain, erythema or induration >10 
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mm in diameter. 
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4. Pump occlusion alarm 
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5. Adhesive failure (only the adhesive on the infusion set will be used) 
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Recording of infusion site information: At home they will examine their infusion site each 
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day for signs of redness and/or induration.  If they detect redness or induration they will 
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record them in mm and send a text to study staff.  At the time an infusion set is removed 
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they will record redness and induration in millimeters, and call one of the investigators if 
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there is more than 10 millimeters of erythema or induration.  They will be given a ruler 
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for making these measurements. Subjects will record the time and date that infusion 
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sets or sensors are removed, and document why they removed the set and take a 
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picture of the infusion site after the infusion set is removed if there is >3 mm of 
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erythema.  The picture and infusion site measurements will be sent via text or e-mail to 
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study staff, if there is not concern about infection. 
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Final Visit 
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Within fourteen days after the study infusion set was inserted, subjects will have their 
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final study visit.  At the final study visit all infusion sets, glucose sensors, study pumps 
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and transmitters provided by the study will be returned. 
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Part 2: Extended Wear Randomized Controlled Crossover Study 
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First Visit 
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Informed Consent Process: The protocol will be reviewed with the subjects, they will be 
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given time to read the informed consent and ask any questions about the study.  
444 
Demographic information for eligibility including age, gender, diabetes duration and 
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duration of pump use will be collected. 
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History and physical exam: Race/ethnicity will be recorded, as well as information about 
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diabetes care including diabetes duration, insulin (Aspart, Lispro, Fiasp or Glulisine), 
449 
average total daily insulin dose, carbohydrate consumption, pump model, CGM model, 
450 
glucometer model and infusion set questionnaire.  DSAT and DDS questionnaires will 
451 
be performed to assess attitudes towards diabetes technology.  Physical exam will be 
452 
performed including vital signs, height, weight, BMI and examination of skin where 
453 
infusion sets and sensors will be inserted. 
454 
 
455 
Laboratory Studies: Point-of-care hemoglobin A1c, and pregnancy test for all females.   
456 
 
457 
Initiation visit and placement of infusion set: Subjects will be block randomized to initially 
458 
wear a Lantern infusion set or an Inset II/Mio (standard infusion set).  At the enrollment 
459 

15 
visit, subjects are provided with study supplies that they do not already have, including 
460 
Dexcom G6 CGM, glucometer, and Precision Xtra ketone meters. Glucometers will be 
461 
tested by study staff to ensure accuracy before being provided to patients.  Education 
462 
will be provided on the use of these devices.  Subjects will continue to use their 
463 
personal insulin pump and insulin as usual.  The patient’s insulin pump will be 
464 
downloaded.  Subjects will be instructed on inserting both infusion sets, which share a 
465 
common insertion procedure.  Infusion sets will be placed in a suitable subcutaneous 
466 
location without ipsilateral or contralateral lipohypertrophy by the patient.  Duration of 
467 
wear will be determined from study part 1.  If a set fails within 24 hours it will be 
468 
replaced with a research infusion set for the study arm they are assigned to.  If a set 
469 
failure occurs after 24 hours, they will return to using their usual infusion set.   
470 
 
471 
Home Monitoring 
472 
Training on home procedures: Subjects will use Dexcom G6 according to manufacturer 
473 
labeling.  While the G6 system is FDA approved for non-adjunctive use without 
474 
calibration, we will ask patients to confirm blood glucose with glucometer prior to 
475 
removing an infusion set.  Subjects will be instructed to check blood ketones using a 
476 
blood ketone meter if there is unexplained hyperglycemia.  Unexplained hyperglycemia 
477 
refers to high glucose levels outside of the usual times they may occur, such as in the 
478 
initial few hours following a meal. If the CGM stops functioning during the study, the 
479 
subjects will insert a new sensor which will be provided to them.  If there is an 
480 
accidental removal of an infusion set the participant will have access to a replacement 
481 
which he or she will be taught to place. 
482 
 
483 
Determination of an infusion set failure: 
484 
They will be instructed to replace the infusion set, in the following situations. 
485 
1. The presence of serum ketones >0.6 mmol/L with meter glucose >250 mg/dL, in 
486 
the absence of illness, vigorous fat burning exercise, starvation or alcohol. 
487 
2. Unexplained hyperglycemia, >250mg/dL, outside anticipated periods of 
488 
carbohydrate consumption, illness, missed insulin doses and menstruation.  This 
489 
hyperglycemia cannot be reduced with appropriate correction doses of insulin 
490 
(such as a decrease of at least 50mg/dL in 1 hour following a correction dose). 
491 
3. Signs of infection at the infusion site including pain, erythema or induration >10 
492 
mm in diameter. 
493 
4. Pump occlusion alarm 
494 
5. Adhesive failure (only the adhesive on the infusion set will be used) 
495 
 
496 
Recording of infusion site information: At home they will exam their infusion site each 
497 
day for signs of redness and/or induration.  If they detect redness or induration they will 
498 
record them in mm and send a text to study staff.  At the time an infusion set is removed 
499 
they will record redness and induration in millimeters, and call one of the investigators if 
500 
there is more than 10 millimeters of erythema or induration.  They will be given a ruler 
501 
for making these measurements. Subjects will record the time and date that infusion 
502 
sets or sensors are removed, and document why they removed the set and take a 
503 
picture of the infusion site after the infusion set is removed if there is ≥ 3 mm of 
504 

16 
induration or erythema.  The picture and infusion site measurements will be sent via text 
505 
or e-mail to study staff, if there is not concern about infection. 
506 
 
507 
Second infusion set placement: After the duration of wear established from study part 1 
508 
elapses the patient will place the second infusion set type in the contralateral body area.  
509 
The same failure criteria and reporting will be used for the other set. 
510 
 
511 
Final Visit 
512 
After the last infusion set was inserted, subjects will have their final study visit to 
513 
evaluate the infusion site. The insertion sites will be examined, erythema, induration and 
514 
local skin reaction will be measured and photographs taken for any significant changes. 
515 
Their insulin pump, CGM, blood glucose and ketone meter will be downloaded.  All 
516 
infusion sets, glucose sensors, study pumps and transmitters provided by the study will 
517 
be returned.  Additionally, the DSAT and DDS questionnaires will be repeated.   
518 

17 
CHAPTER 4: Adverse Event Reporting and Protocol Monitoring 
519 
 
520 
Definition 
521 
A reportable adverse event is any untoward medical occurrence that meets criteria for a 
522 
serious adverse event or any unexpected medical occurrence in a study subject that is 
523 
study or device-related.  Skin irritation from sensor wear will be recorded in specific 
524 
sections of the case report forms.  An adverse event form is only completed if skin 
525 
irritation is severe or antibiotics are required.   
526 
 
527 
Hypoglycemic events are recorded as Adverse Events if the event required assistance 
528 
of another person due to altered consciousness to actively administer carbohydrate, 
529 
glucagon, or other resuscitative actions.  This means that the subject was impaired 
530 
cognitively to the point that he/she was unable to treat him or herself, was unable to 
531 
verbalize his or her needs, was incoherent, disoriented, and/or combative, or 
532 
experienced seizure or coma.  These episodes may be associated with sufficient 
533 
neuroglycopenia to induce seizure or coma.  If plasma glucose measurements are not 
534 
available during such an event, neurological recovery attributable to the restoration of 
535 
plasma glucose to normal is considered sufficient evidence that the event was induced 
536 
by a low plasma glucose concentration.   
537 
 
538 
Hyperglycemic events are recorded as Adverse Events if the event involved diabetic 
539 
ketoacidosis, as defined by the DCCT, and had all of the following:  
540 
1. Symptoms such as polyuria, polydipsia, nausea, or vomiting 
541 
2. Serum ketones greater than 1.6 mM, or large/moderate urine ketones 
542 
3. Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15 
543 
4. Treatment provided in a health care facility 
544 
 
545 
Recording of Adverse Events 
546 
Throughout the course of the study, all efforts will be made to remain alert to possible 
547 
adverse events or untoward findings.  The first concern will be the safety of the subject, 
548 
and appropriate medical intervention will be made. 
549 
 
550 
The investigator will elicit reports of adverse events from the subject at each visit and 
551 
complete all adverse event forms online.  Each adverse event form is reviewed by the 
552 
Coordinating Center to verify the coding and the reporting that is required.  
553 
 
554 
The study investigator will assess the relationship of any adverse event to be related or 
555 
unrelated by determining if there is a reasonable possibility that the adverse event may 
556 
have been caused by the study device or study procedures.    
557 
 
558 
The intensity of adverse events will be rated on a three point scale: (1) mild, (2) 
559 
moderate, or (3) severe.  It is emphasized that the term severe is a measure of 
560 
intensity: thus a severe adverse event is not necessarily serious.  For example, itching 
561 
for several days may be rated as severe, but may not be clinically serious.   
562 
 
563 

18 
Adverse events that continue after the participant’s discontinuation or completion of the 
564 
study will be followed until their medical outcome is determined or until no further 
565 
change in the condition is expected.  
566 
 
567 
Adverse events will be coded using the MedDRA dictionary.  
568 
 
569 
Definitions of relationship and intensity are listed on the website data entry form.   
570 
 
571 
Adverse events that continue after the subject’s discontinuation or completion of the 
572 
study will be followed until their medical outcome is determined or until no further 
573 
change in the condition is expected.     
574 
 
575 
Reporting Serious or Unexpected Adverse Events 
576 
A serious adverse event is any untoward occurrence that: Results in death; is life-
577 
threatening (a non life-threatening event which, had it been more severe, might have 
578 
become life-threatening, is not necessarily considered a serious adverse event); 
579 
requires inpatient hospitalization or prolongation of existing hospitalization; results in a 
580 
disability or permanent damage which causes a substantial disruption of a person's 
581 
ability to conduct normal life functions; results in a congenital anomaly/birth defect;  
582 
requires intervention to prevent permanent impairment or damage (Devices); or any 
583 
other serious (Important Medical Event) which may jeopardize the patient and may 
584 
require medical or surgical intervention (treatment) to prevent a serious adverse event. 
585 
 
586 
An Unanticipated Adverse Device Event is defined as an adverse event caused by, or 
587 
associated with, a device, if that effect or problem was not previously identified in 
588 
nature, severity, or degree of incidence. 
589 
 
590 
Serious or unexpected adverse events must be reported to the Principal Investigator 
591 
immediately.  
592 
Bruce Buckingham, M.D. 
593 
Division of Endocrinology and Diabetes 
594 
780 Welch Road, Room CJ320H 
595 
Palo Alto, CA 94305 
596 
Office Phone 650-725-6549 
597 
Office Fax 650-736-6690 
598 
 
599 
The principle investigator will notify all participating investigators of any adverse device 
600 
event that is both serious and unexpected. Notification will be made within 10 days after 
601 
becoming aware of the event.  
602 
 
603 
Each investigator is responsible for informing his/her IRB of serious study-related 
604 
adverse events and abiding by any other reporting requirements specific to their IRB.  
605 
 
606 
If a serious or unexpected adverse event occurs, the Principal Investigator will prepare 
607 
a report to the study sponsor within 5 days, and a report will also be sent to the IRB and 
608 
FDA within 10 days if the adverse event is serious or an unexpected device event.  The 
609 

19 
principal investigators will meet to decide the appropriate action to be taken, i.e. 
610 
continue study unmodified, modify study or stop study. 
611 
 
612 
Potential Risks and Side Effects 
613 
Local Reaction 
614 
With insulin infusion sets there is a low risk for developing local skin infections which 
615 
may be increased by the prolonged wear of infusion sets from the recommended 3 days 
616 
to 10 days for this study.   Itchiness, redness, bleeding, and bruising at the insertion site 
617 
might also occur. Local tape allergy is a possibility as well.  These risks may also be 
618 
increased when patients use insulin infusion sets for longer than 3 days.   
619 
 
620 
Invasive Testing 
621 
All subjects will be required to perform fingerstick blood glucose tests and fingerstick for 
622 
measurement of HbA1c.  While part of routing diabetes care, this can be painful and 
623 
distressing to some patients. There is a very slight risk of infection and bruising at the 
624 
site of the fingerstick. 
625 
 
626 
Hypoglycemia 
627 
As with any person having insulin-dependent diabetes, there is always a risk of having a 
628 
low blood sugar (hypoglycemia).  The frequency of nocturnal hypoglycemia should be 
629 
no more than it would be as part of daily living with diabetes.  Symptoms of 
630 
hypoglycemia can include sweating, jitteriness, and not feeling well.  Just as at home, 
631 
there is the possibility of loss of consciousness or seizures (convulsions) and that for a 
632 
few days you may not be as aware of symptoms of low blood sugar.  Even if severe low 
633 
blood sugar does occur, it almost always goes away quickly with treatment to raise the 
634 
blood sugar.  
635 
 
636 
Hyperglycemia 
637 
Since we are asking subjects to wear an insulin infusion set for 10 days, there will be a 
638 
higher risk for hyperglycemia occurring than would occur if infusion sets were changed 
639 
every three days.  A delayed change in an infusion set could therefore cause an 
640 
additional episode of hyperglycemia with extended infusion set wear.  Since subjects 
641 
will be performing frequent monitoring of their blood glucose and monitoring blood 
642 
ketone levels in the event of hyperglycemia, these events should be of limited duration 
643 
and ketosis should be detected early and easily treated. 
644 
 
645 
Protection against Risks and Treatment of Side Effects 
646 
Subjects will be given descriptions of possible local side effects with insulin infusion sets 
647 
or sensor insertion sets. They will be told to contact the study staff if they see any signs 
648 
of a skin reaction.  Based on the severity of local skin reaction, topical anti-inflammatory 
649 
medications can be used (such as topical steroids). 
650 
 
651 
Subjects will be instructed on the signs and symptoms of hypoglycemia and 
652 
hyperglycemia, and appropriate management to correct these states.  They will be 
653 
instructed in the use of glucagon emergency kit for reversal of severe hypoglycemia.  
654 
For hyperglycemia, they will be instructed to ensure the insulin pump is appropriately 
655 

20 
functioning, and there are no obstructions in the insulin infusion set. They will also be 
656 
instructed to check serum ketones. If hyperglycemia persists, they will be instructed to 
657 
use subcutaneous insulin injections, and change to a new insulin infusion set. 
658 
 
659 
All subjects that wish to have a topical anesthetic applied prior to inulin infusion set and 
660 
Continuous Glucose Monitoring (CGM) sensor insertion will have this option available to 
661 
them.  
662 
 
663 
Other Risks 
664 
Some subjects may develop skin irritation or allergic reactions to the adhesives used to 
665 
secure the CGM sensor or infusion set.  If these reactions occur, different adhesives or 
666 
“under-taping” (such as with IV 3000, Tegaderm, etc.) will be tried, sites will be rotated 
667 
frequently, and a mild topical steroid cream or other medication may be required. 
668 
 
669 
Whenever the skin is broken there is the possibility of an infection.  The CGM sensor 
670 
and insulin infusion set sites are inserted under the skin.  It is possible that any part that 
671 
is inserted under the skin may cause an infection.  These occur infrequently, but, if an 
672 
infection was to occur, oral and/or topical antibiotics can be used, and they generally 
673 
respond quickly to a short course of oral antibiotics such as cefaclor.  The risk of skin 
674 
problems could be greater if a sensor or infusion set is used for extended periods of 
675 
time.  Therefore participants will be carefully instructed about daily inspection of their 
676 
sensor and infusion set sites. 
677 
 
678 
Data downloaded from the CGM sensor, insulin pump, and the home glucose and 
679 
ketone meters will be collected for the study as measures of diabetes self-management 
680 
behaviors.  Some people may be uncomfortable with the researchers having such 
681 
detailed information about their daily diabetes habits. 
 
682 

21 
CHAPTER 5: Miscellaneous Considerations 
683 
 
684 
Potential Benefits 
685 
Continuous Glucose Monitoring (CGM) data will provide each subject individualized 
686 
information about their glucose response to variables such as meals and exercise that 
687 
may help in their management of diabetes.  
688 
 
689 
The ability to wear an infusion set for extended periods may help decrease local skin 
690 
reactions from the frequent insertion and removal of infusion sets which results in 
691 
removal of portions of the top layer of the epidermis which may lead to a higher risk of 
692 
infections if a new infusion set or sensor is inserted into this area before the epidermis is 
693 
completely healed.   
694 
 
695 
If there is less unexplained hyperglycemia and fewer episodes of ketosis with prolonged 
696 
infusion set wear as a result of the Lantern infusion set, this would be a significant 
697 
benefit to all people using insulin infusion pumps. 
698 
 
699 
If the Lantern infusion set could extend the use of a subcutaneous infusion sets to 7-10 
700 
days, this would allow of the future development of a combination infusion set and 
701 
continuous glucose sensor.   Such a platform would play an integral role in the 
702 
development of a simplified closed-loop artificial pancreas system. 
703 
 
704 
Subject Compensation 
705 
Subjects will be compensated $50 for each outpatient study visit and $20 for each entry 
706 
into REDCap or contact with a study investigator.  Maximum payment of $280 for all 
707 
study visits in Part 1 and $530 for participating in Part 2.  Compensation of partial 
708 
participation will be prorated.   
709 
 
710 
Subject Withdrawal 
711 
Participation in the study is voluntary, and a subject may withdraw at any time.  The 
712 
investigator may withdraw a subject who is not complying with the protocol. For subjects 
713 
who withdraw, their data will be used up until the time of withdrawal. 
714 
 
715 
Subject Discontinuation Criteria 
716 
Subjects who become pregnant will be discontinued from the study.  The investigator 
717 
may withdraw a subject who is not complying with the protocol. Withdrawal of a subject 
718 
will be considered for the following reasons: 
719 
1. Failure to monitor their sensor and infusion sites on a daily basis 
720 
2. Developing >1.0 mmol/L ketones on 2 or more occasions and failing to change 
721 
their infusion set or a single episode of diabetic ketoacidosis due to an infusion 
722 
site failure 
723 
 
724 
For subjects who withdraw or who are withdrawn, their data will be used for analysis 
725 
purposes up until the time of withdrawal. 
726 
 
727 

22 
Confidentiality 
728 
For security and confidentiality purposes, subjects will be assigned an identifier that will 
729 
be used instead of their name.  De-identified subject information may be provided to the 
730 
funder.   
731 
 
732 
Level of Risk 
733 
This research proposal in children is consistent with United States Department of Health 
734 
and Human Services, Protection of Human Subjects, Subpart D, Section 46.404 
735 
(Research not involving more than minimal risk).   
736 
 
737 
Planned Duration of the Entire Study 
738 
Planned duration of the entire study will be 12 months.  
 
739 

23 
CHAPTER 6: Statistical Considerations 
740 
 
741 
Part 1 
742 
Before beginning a larger cross-over study we would perform this pilot study to 
743 
determine the maximum length of Lantern infusion set wear when 80% are still 
744 
functional if failure was not due the infusion set being accidentally pulled out.  This study 
745 
is not statistically powered.     
746 
 
747 
Part 2 
748 
Primary Outcome 
749 
Our primary outcome will be time to failure of each infusion set.  We have reviewed 353 
750 
weeks of infusion set wear from prior studies [19-20, unpublished data] and subjects 
751 
who wear the control set have an average length of wear of 5.1 days with a standard 
752 
deviation of 1.7 days and intra-subject correlation of 0.69.  For a meaningful clinical 
753 
benefit, the subjects who wear the treatment set should extend wear by at least 1 day to 
754 
an average length of wear of 6.1 days.  A sample size of 40 subjects will provide 95% 
755 
power to detect a difference of 1 day in the average length of wear in a two-sided test 
756 
with an alpha level of 0.05.  A minimum of 25 subjects must be recruited for 80% power. 
757 
 
758 
Exploratory Outcomes 
759 
Other outcomes will include – BMI, cause of infusion set failure, measurements of 
760 
erythema and induration, pump insulin delivery data, glucometer readings, ketone meter 
761 
data, average daily CGM blood glucose, DSAT/DDS score and infusion set 
762 
questionnaire. 
763 
 
764 
We will summarize the other secondary measures using means, standard deviation, 
765 
medians, ranges, proportions and 95% confidence interval, as appropriate.  We will also 
766 
explore the relationship between BMI, DSAT/DDS score and the time to failure primary 
767 
outcome.  Finally, we will test if there is a significant change in the DSAT/DDS score 
768 
following participation in the clinical trial. 
 
769 

24 
CHAPTER 7: References 
770 
 
771 
1. The Diabetes Control and Complications Trial Research Group.  “The effect of 
772 
intensive treatment of diabetes on the development and progression of long-term 
773 
complications in insulin-dependent diabetes mellitus. The Diabetes Control and 
774 
Complications Trial Research Group.”  N Engl J Med. 1993 Sep 30;329(14):977-
775 
86. 
776 
2. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions 
777 
and Complications (DCCT/EDIC) Study Research Group.  “Intensive diabetes 
778 
treatment and cardiovascular disease in patients with type 1 diabetes.”  N Engl J 
779 
Med. 2005 Dec 22;353(25):2643-53. 
780 
3. Yeh HC, Brown TT, Maruthur N, Ranasinghe P, Berger Z, Suh YD, Wilson LM, 
781 
Haberl EB, Brick J, Bass EB, Golden SH.  “Comparative effectiveness and safety 
782 
of methods of insulin delivery and glucose monitoring for diabetes mellitus: a 
783 
systematic review and meta-analysis.”  Ann Intern Med. 2012 Sep 4;157(5):336-
784 
47. 
785 
4. Brorsson AL, Viklund G, Örtqvist E, Lindholm Olinder A.  “Does treatment with an 
786 
insulin pump improve glycaemic control in children and adolescents with type 1 
787 
diabetes? A retrospective case-control study.”  Pediatr Diabetes. 2015 
788 
Nov;16(7):546-53. 
789 
5. Rosenlund S, Hansen TW, Andersen S, Rossing P.  “Effect of 4 years subcutaneous 
790 
insulin infusion treatment on albuminuria, kidney function and HbA1c compared 
791 
with multiple daily injections: a longitudinal follow-up study.”  Diabet Med. 2015 
792 
Nov;32(11):1445-52. 
793 
6. Szypowska A, Schwandt A, Svensson J, Shalitin S, Cardona-Hernandez R, 
794 
Forsander G, Sundberg F, De Beaufort C, Maahs D, Maffeis C, O'Riordan SM, 
795 
Krisane ID, Scharf M, Castro S, Konstantinova M, Obermannova B, Casteels K, 
796 
Gökşen D, Galhardo J, Kanaka-Gantenbein C, Rami-Merhar B, Madacsy L; 
797 
SWEET Study Group.  “Insulin pump therapy in children with type 1 diabetes: 
798 
analysis of data from the SWEET registry.”  Pediatr Diabetes. 2016 Oct;17 Suppl 
799 
23:38-45. 
800 
7. Heinemann L, Krinelke L.  “Insulin Infusion Set: The Achilles Heel of Continuous 
801 
Subcutaneous Insulin Infusion.”  J Diabetes Sci Technol. 2012 Jul; 6(4): 954–
802 
964. 
803 
8. Pfützner A, Sachsenheimer D, Grenningloh M, Heschel M, Walther-Johannesen L, 
804 
Gharabli R, Klonoff D.  “Using Insulin Infusion Sets in CSII for Longer Than the 
805 
Recommended Usage Time Leads to a High Risk for Adverse Events: Results 
806 
From a Prospective Randomized Crossover Study.”  J Diabetes Sci Technol. 
807 
2015 Sep 3;9(6):1292-8. 
808 
9. Schmid V, Hohberg C, Borchert M, Forst T, Pfützner A.  “Pilot study for assessment 
809 
of optimal frequency for changing catheters in insulin pump therapy-trouble starts 
810 
on day 3.”  J Diabetes Sci Technol. 2010 Jul 1;4(4):976-82. 
811 
10. Sampson Perrin AJ, Guzzetta RC, Miller KM, Foster NC, Lee A, Lee JM, Block JM, 
812 
Beck RW; T1D Exchange Clinic Network.  “A web-based study of the relationship 
813 
of duration of insulin pump infusion set use and fasting blood glucose level in 
814 
adults with type 1 diabetes.”  Diabetes Technol Ther. 2015 May;17(5):307-10.  
815 

25 
11. Brown A, Close K. "FDA Clears Dexcom G6 CGM with No Fingersticks! Launch 
816 
Later This Year." DiaTribe. N.p., 29 Mar. 2018. Web. 05 Apr. 2018. 
817 
12. Smalley E.  "Medtronic automated insulin delivery device gets FDA nod."  Nature 
818 
Biotechnology.  2016 Dec; 34: 1220. 
819 
13. Tansey M, Laffel L, Cheng J, Beck R, Coffey J, Huang E, Kollman C, Lawrence J, 
820 
Lee J, Ruedy K, Tamborlane W, Wysocki T, Xing D; Juvenile Diabetes Research 
821 
Foundation Continuous Glucose Monitoring Study Group.  "Satisfaction with 
822 
continuous glucose monitoring in adults and youths with Type 1 diabetes."  
823 
Diabet Med. 2011 Sep;28(9):1118-22.  
824 
14. Becker B. "Why Do Some People with T1D Stop Using a Pump and CGM?" T1D 
825 
Exchange. Web. 04 Apr. 2017. 
826 
15. Nørgaard K, Shin J, Welsh JB, Gjessing H.  “Performance and acceptability of a 
827 
combined device for insulin infusion and glucose sensing in the home setting.”  J 
828 
Diabetes Sci Technol. 2015 Mar;9(2):215-20. 
829 
16. Rumpler M, Mader JK, Fischer JP, Thar R, Granger JM, Deliane F, Klimant I, Aberer 
830 
F, Sinner F, Pieber TR, Hajnsek M.  “First application of a transcutaneous optical 
831 
single-port glucose monitoring device in patients with type 1 diabetes mellitus.”  
832 
Biosens Bioelectron. 2017 Feb 15;88:240-248. 
833 
17. Bode BW, Strange P. Efficacy, safety, and pump compatibility of insulin aspart used 
834 
in continuous subcutaneous insulin infusion therapy in patients with type 1 
835 
diabetes. Diabetes Care. 2001;24:69-72. 
836 
18. Thethi TK, Rao A, Kawji H, Mallik T, Yau CL, Christians U, Fonseca V. 
837 
Consequences of delayed pump infusion line change in patients with type 1 
838 
diabetes mellitus treated with continuous subcutaneous insulin infusion. Journal 
839 
of diabetes and its complications.  2010;24:73-8. 
840 
19. Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham 
841 
BA. “Randomized trial of infusion set function: steel versus teflon.”  Diabetes 
842 
Technol Ther. 2014 Jan;16(1):15-9.  
843 
20. Karlin AW, Ly TT, Pyle L, Forlenza GP, Messer L, Wadwa RP, DeSalvo DJ, Payne 
844 
SL, Hanes S, Clinton P, Maahs DM, Buckingham B.  “Duration of Infusion Set 
845 
Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with 
846 
Type 1 Diabetes.”  Diabetes Technol Ther. 2016 Jul;18(7):429-35. 
847 
21. Naranjo D, Tanenbaum ML, Iturralde E, Hood KK.  “Diabetes Technology: Uptake, 
848 
Outcomes, Barriers, and the Intersection With Distress.”  J Diabetes Sci Technol. 
849 
2016 Jun 28;10(4):852-8. 
850 
22. Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA.  
851 
“Assessing psychosocial distress in diabetes: development of the diabetes 
852 
distress scale.”  Diabetes Care. 2005 Mar;28(3):626-31. 
853