Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.

Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial.

OBJECTIVES: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling. METHODS: In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss. RESULTS: At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group. CONCLUSIONS: The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Usability and training differences between two personal insulin pumps.

The purpose of this study was to determine if there were usability and training differences between the Medtronic MiniMed Paradigm Revel Insulin Pump and the Tandem Diabetes Care t:slim Insulin Pump during use by representative users, performing representative tasks, in a simulated use environment. This study utilized a between-subjects experimental design with a total of 72 participants from 5 sites across the United States. Study participants were randomized to either the Revel pump group or the t:slim Pump group. Participants were 18 years of age or older and managed their diabetes using multiple daily insulin injections. Dependent variables included training time, training satisfaction, time on task, task failures, System Usability Scale (SUS) ratings, perceived task difficulty, and a pump survey that measured different aspects of the pumps and training sessions. There was a statistically significant difference in training times and error rates between the t:slim and Revel groups. The training time difference represented a 27% reduction in time to train on the t:slim versus the Revel pump. There was a 65% reduction in participants' use error rates between the t:slim and the Revel group. The t:slim Pump had statistically significant training and usability advantages over the Revel pump. The reduction in training time may have been a result of an optimized information architecture, an intuitive navigational layout, and an easy-to-read screen. The reduction in use errors with the t:slim may have been a result of dynamic error handling and active confirmation screens, which may have prevented programming errors.

TheV-Go insulin delivery device used in clinical practice: patient perception and retrospective analysis of glycemic control.

OBJECTIVE: To describe patient perceptions regarding their experience and to report findings in a retrospective analysis of glycemic control in a cohort of patients who used the V-Go, a mechanical, 24-hour disposable, subcutaneous continuous insulin delivery device that delivers a preset basal infusion rate and on-demand insulin. METHODS: Patients used the V-Go and answered telephone surveys about their perception of device use. Corresponding clinical data were retrospectively collected before V-Go initiation, after 12 weeks of use, at the end of treatment, and 12 weeks after discontinuation. Analyses were performed with nonparametric statistical tests. RESULTS: Twenty-three patients participated. Mean values of the following characteristics were documented: patient age, 61 years; body mass index, 30 kg/m2; diabetes duration, 16 years; duration of insulin therapy, 7 years; average duration of V-Go use, 194 days; and mean total daily insulin dose, 50 U at baseline, 46 U while on V-Go, and 51 U after stopping V-Go treatment. Mean patient rating of the overall experience was 9.1 at 12 weeks on a scale from 1 to 10 (10 being most positive). Mean hemoglobin A1c value decreased from baseline (8.8% to 7.6%; [P = .005]) while using the V-Go, and it increased to 8.2% after treatment. Fasting plasma glucose trended from 205 mg/dL at baseline to 135 mg/dL while using V-Go and increased to 164 mg/dL after V-Go was stopped. Weight was essentially unchanged. No differences in hypoglycemic events were found; site reactions were minor. CONCLUSION: Glycemic control improved when patients were switched to the V-Go for insulin delivery, and it deteriorated when the V-Go was discontinued.

Evaluation of treatment satisfaction associated with the use of insulin aspart in continuous subcutaneous insulin infusion.

BACKGROUND: The purpose of this study was to compare treatment satisfaction among people with type 1 and type 2 diabetes after switching from insulin lispro to insulin aspart in continuous subcutaneous insulin infusion (CSII). Efficacy of glycemic control between treatments was also investigated. METHODS: Subjects using CSII with insulin lispro for 6 months or longer continued this therapy over a 4-week period and then switched to insulin aspart in CSII for 12 weeks. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Insulin Treatment Satisfaction Questionnaire (ITSQ) were administered immediately prior to the switch and again at the end of 12 weeks of therapy with insulin aspart. Hemoglobin A(1c)(A1C) and fasting blood glucose (FBG) levels, insulin dose, and body weight were recorded at the same time points. RESULTS: Although average overall DTSQ score did not change significantly, average overall ITSQ score was significantly improved following the insulin aspart treatment. There was a small but statistically significant reduction in mean A1C and FBG following 12 weeks of CSII using insulin aspart. CONCLUSIONS: Both insulin aspart and insulin lispro are appropriate for CSII. ITSQ improvements suggest that aspects of CSII therapy with insulin aspart positively impact treatment satisfaction.

Complications of type 2 diabetes mellitus: a brief overview.

The recent findings of the United Kingdom Prospective Diabetes Study (UKPDS) have focused attention on the need to prevent complications in type 2 diabetes mellitus. Understanding the pathogenesis and physiologic mechanisms that lead to complications in the patients with type 2 diabetes mellitus is imperative to prevent their progression and improve treatment. This article discusses the more common complications and their possible etiologies, progression, and contribution to the morbidity of the diabetic population. It also reviews treatment of these complications and recent advances. In addition, some of the less common complications will be identified so that primary care physicians and specialists will be aware and not overlook these in patients who can be treated early and aggressively.