Developing a Simple 3-Day Insulin Delivery Device to Meet the Needs of People With Type 2 Diabetes.

AIM: We sought to design an insulin delivery method that would overcome barriers to insulin therapy and meet the needs of the users, adults with diabetes, and their health care providers (HCPs). METHODS: We conducted focus groups and human factors studies with users to learn about their needs and requirements. We then designed an insulin delivery device, PAQ, with features that met the user's requirements. Iterative design and human factors testing (HFT) was performed with adults with diabetes on ⩾2 injections/day and HCPs. In parallel, studies were conducted to identify an adhesive that stayed adhered for 3 days and caused minimal, if any, dermal irritation. Pilot clinical studies were then initiated. RESULTS: Users want a way to administer insulin that is simple, discreet, safe, and effective. A summative HFT found the device was easy to learn and use. All participants (30/30, 100%) successfully completed the key performance measures tested. An adhesive validation study in 30 adults with diabetes found 90% of the devices remained adhered to the participant's application site at the end of 3 days with minimal skin irritation. Data from 3 clinical studies revealed 74-75% transitioned from injectable insulin to the device with the first fixed basal rate selected, improved glycemic control, and participants' satisfaction with the device. CONCLUSION: The collective data from the HFT, adhesive, and clinical studies demonstrated that the device provides a method of insulin delivery that overcomes barriers to injectable insulin, meets the needs of the user, and achieves glycemic control.

Novel simple insulin delivery device reduces barriers to insulin therapy in type 2 diabetes: results from a pilot study.

BACKGROUND: The PaQ® insulin delivery system is a simple-to-use patch-on device that provides preset basal rates and bolus insulin on demand. In addition to feasibility of use, safety, and efficacy (reported elsewhere), this study analyzed the impact of PaQ on patient-reported outcomes, including barriers to insulin treatment, diabetes-related distress, and attitudes toward insulin therapy in patients with type 2 diabetes on a stable multiple daily injection (MDI) regimen. METHODS: This single-center, open-label, single-arm study comprised three 2-week periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment. Validated questionnaires were administered during the baseline and PaQ treatment periods: Barriers to Insulin Treatment questionnaire (BIT), Insulin Treatment Appraisal Scale (ITAS), and Problem Areas in Diabetes scale (PAID). RESULTS: Eighteen patients (age 59 ± 5 years, diabetes duration 15 ± 7 years, 21% female, HbA1c 7.7 ± 0.7%) completed the questionnaires. There was a strong, significant effect of PaQ use in mean BIT total scores (difference [D] = -5.4 ± 0.7.7, P = .01, effect size [d] = 0.70). Patients perceived less stigmatization by insulin injection (D = -2.2 ± 6.2, P = .18, d = 0.35), increased positive outcome (D = 1.9 ± 6.6, P = .17, d = 0.29), and less fear of injections (1.3 ± 4.8, P = .55, d = 0.28). Mean change in ITAS scores after PaQ device use showed a nonsignificant improvement of 1.71 ± 5.63 but moderate effect size (d = 0.30, P = .14). No increase in PAID scores was seen. CONCLUSIONS: The results and moderate to large effects sizes suggest that PaQ device use has beneficial and clinically relevant effects to overcoming barriers to and negative appraisal of insulin treatment, without increasing other diabetes-related distress.

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

OBJECTIVE: This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. RESULTS: Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. CONCLUSIONS: PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

De novo bone induction by recombinant human bone morphogenetic protein-2 (rhBMP-2) in maxillary sinus floor augmentation.

PURPOSE: This phase II study was designed to evaluate 2 concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) for safety and efficacy in inducing adequate bone for endosseous dental implant in patients requiring staged maxillary sinus floor augmentation. MATERIALS AND METHODS: Patients were treated with rhBMP-2 (via an absorbable collagen sponge [ACS]), at concentrations of 0.75 mg/mL (n = 18), 1.50 mg/mL (n = 17), or with bone graft (n = 13). Bone induction was assessed by alveolar ridge height, width, and density measurements from computed tomography scans obtained before and 4 months after treatment and 6 months post-functional loading of dental implants (density only). RESULTS: Mean increases in alveolar ridge height at 4 months after treatment were similar among the groups; 11.3 mm, 9.5 mm, and 10.2 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL rhBMP-2/ACS treatment groups. Mean increases in alveolar ridge width (buccal to lingual) at the crest of the ridge were statistically different among the treatment groups; 4.7 mm, 2.0 mm, and 2.0 mm, respectively, in the bone graft, 0.75 mg/mL, and 1.50 mg/mL treatment groups (P

Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.

BACKGROUND: Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction. METHODS: Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (> or =50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation. RESULTS: Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P < or =0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone. CONCLUSION: The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants.