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.
These 3-year results demonstrate that rhBMP-2/ACS can be used safely in human patients. Human bone biopsies reveal normal bone formation in areas treated with rhBMP-2/ACS. Endosseous implants placed in these areas were all stable with no radiographic or clinical complications. The results from this study suggest that rhBMP-2/ACS (0.43 mg/ml) can be safely used in tooth extraction sites and in local ridge augmentation procedures and that endosseous dental implants placed in bony areas treated with rhBMP-2/ACS are stable and can be functionally restored without complication.
OBJECTIVEThis 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 METHODSTwenty 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.
RESULTSNineteen 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. Continuous subcutaneous insulin infusion has the potential to improve glycemic control and quality of life in individuals with type 2 diabetes (T2D) (1-6) but is not widely used in this population due to cost, device complexity, and extensive training requirements (7). Although currently available insulin pumps can be programmed to deliver up to 48 different basal rates per day, data from recent studies show good glycemic control in T2D by using only one or two daily basal rates (6,8). We tested a new, small, and discreet insulin delivery device (PaQ; CeQur SA, Horw, Switzerland) specifically designed for individuals with T2D. PaQ is directly applied to the skin, and insulin is infused at a constant basal rate for 3 days at one of five preset basal rates (Fig. 1A and B).
RESEARCH DESIGN AND METHODSThis 6-week, prospective, single-arm, single-center pilot study evaluated the feasibility of using PaQ in individuals with T2D currently treated with multiple daily injections (MDI). The study comprised three, two-week study periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment.
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