Research News: Diabetic Foot Ulcers, Diabetes Prevention, Slowing Early T2DM Progression


Smart Insoles Reduce “High-Risk” Diabetic Foot Ulcer Recurrence

Smart insoles that warn individuals with diabetes mellitus (DM) of high plantar pressures could be a simple solution to help them avoid recurrent foot ulcers, according to the results of a randomized trial.

Study participants with a history of diabetic foot ulcers wore the plantar pressure-sensing insoles (SurroSense Rx) and received feedback via sensor linked to a smart watch worn and were 71% less likely to experience a recurrent foot ulceration than were those who wore the insoles but did not get the pressure feedback (incidence rate ratio, 0.29; 95% CI, 0.09-0.93; P = .037). The device has been cleared by the US Food and Drug Administration.

Overall, there were few ulcers that occurred in the study, with 10 ulcers from 8,638 person-days from 6 patients reported in the control group and 4 ulcers from 11,835 person-days from 4 patients in the intervention group.

“Diabetic foot ulcers are a major global health and economic burden, but, in theory at least, they are ultimately preventable,” said study investigator Neil Reeves, PhD, who presented the findings at the annual meeting of the European Association for the Study of Diabetes.

The smart insoles incorporate 8 discreet pressure sensors that are connected to a pod worn on the front of the participant’s own shoe and that wirelessly relay pressure information to a smartwatch. Both the control and the intervention groups received the same device, Dr. Reeves pointed out, but the difference was that only the intervention group got any pressure feedback from the sensors to the smartwatch.

In all, there were 58 study participants—32 randomized to the intervention group and 26 to the control group—who had a history of diabetic foot ulcers and peripheral neuropathy but who were able to walk independently for at least 30 steps. The mean age of patients in the intervention group was 59 years, 88% were male, 72% had type 2 DM (T2DM), and the mean duration of DM was 22 years. Corresponding data in the control group were 67 years, 89% male, 85% had T2DM, and 21 years’ DM duration.

Dr. Reeves noted that there was no significant difference in the time to ulceration between the groups, with 77.5% and 68.4% of the intervention and control group remaining ulcer free at 18 months (P = .30). When the data were adjusted for adherence, there was an 86% reduction in the risk of reulceration in the intervention versus the control group (IRR, 0.14; 95% CI, 0.03-0.63; P = .011). This analysis took into account only those study participants who had 4.5 hours or more of daily wear of the smart insoles (n = 40). On average, the insoles were worn for 6.1 hours in the control group and 6.9 hours in the intervention group.

“We suggest that the mechanism for this beneficial effect in the present study is likely pressure offloading, which has been afforded by providing patients in the intervention group with this plantar-pressure feedback,” said Dr. Reeves.

Diabetes UK provided the primary funding for the study (years 1-3), with Orpyx Medical Technologies, Canada, providing funding during the study extension (year 4). Dr. Reeves did not have any disclosures.

Sara Freeman, Clinical Endocrinology News

VA’s Online Diabetes Prevention Program as Good as Face-to-Face Programs

An intensive and multifaceted online diabetes mellitus (DM) prevention program is as effective as face-to-face programs and has the potential to expand reach to those at risk of developing diabetes, researchers report.

Writing in background information to their paper, Tannaz Moin, MD, an endocrinologist at the US Department of Veterans Affairs (VA) Greater Los Angeles Healthcare System’s Center for the Study of Healthcare Innovation, Implementation, and Policy, and her associates, said intensive lifestyle interventions such as diabetes prevention programs (DPP) could lower the risk of incident DM by 58%, but a lack of reach significantly attenuated their population impact in real-world settings.

“Building evidence for online DPP is important because of its potential for increasing reach because most U.S. adults (87%) use the Internet,” they wrote in their paper, published in the American Journal of Preventive Medicine.

They therefore set out to compare weight loss results from 114 veterans taking part in the VA face-to-face standard-of care weight management program MOVE! with an online program involving 268 obese or overweight veterans with prediabetes and 273 people taking part in an in-person program.

MOVE! included 8 to 12 face-to-face healthy-lifestyle sessions and monthly maintenance sessions but with no specified goals. The online program involved virtual groups of participants: live e-coaches who monitored group interactions and provided the participants with feedback via phone and private online messages; weekly educational modules on healthy eating and exercise; and wireless scales to record participant weights.

The in-person program consisted of 8 to 22 group-based face-to-face sessions focused on 7% weight loss and at least 150 minutes per session of moderate physical activity.

Weight loss, considered by the authors to be a significant predictor of DM risk reduction, was recorded at 6 months and then again at 12 months in all 3 interventions.

An analysis of 242 participants enrolled in the intensive, multifaceted online DPP intervention (26 were excluded because they did not have more than 2 available weights) revealed a significant weight change of -4.7 kg at 6 months and -4 kg at 12 months’ follow-up. On average, these participants lost 3.7% of their baseline weight at 12 months.

At both times weight change (kg and percentage) was not significantly different between the online intervention and those taking part in the in-person DPP (-4.8 and -4.1 kg for online vs -4 kg and -3.9 kg in-person for those completing more than 1 module/session). Both groups also had higher weight loss (percentage and kg) at 6 and 12 months compared with MOVE! participants (-1.1 kg and 0.10 kg).

The research team noted that the online program had better participation than did the in-person program, with 87% of online participants completing 8 or more sessions, compared with 59% for the in-person program and 55% for MOVE!

They suggested this was because the online program had several user-friendly features that increased the frequency of potential “touches” participants received over time.

“Future studies examining how inline DPP intervention components can work together to impact participation and engagement are key,” they said.

“This is one of the first studies to report weight outcomes irrespective of the level of engagement with an online DPP intervention and to examine outcomes compared with in person DPP. Overall, these findings may have important implications for national efforts to disseminate DPP,” they concluded.

Nicola Garrett, Clinical Endocrinology News

Gastric Banding, Metformin “Equal” for Slowing Early T2DM Progression

Gastric banding surgery and metformin produce similar improvements in insulin sensitivity and parameters indicative of preserved beta-cell function in patients with impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes mellitus (T2DM), according to the results
of a study conducted by the Restoring Insulin Secretion (RISE) Consortium.

“Both interventions resulted in about 50% improvements in insulin sensitivity at 1 year, which was attenuated at 2 years,” reported study investigator Thomas Buchanan, MD, of the University of Southern California, Los Angeles, at the annual meeting of the European Association for the Study of Diabetes.

“The beta-cell responses fell in a pattern that maintained relatively, but not perfectly, stable compensation for insulin resistance,” he added.

Although glucose levels improved “only slightly,” he said, “acute compensation to glucose improved significantly with gastric banding and beta-cell compensation at maximal stimulation fell significantly with metformin.”

Results of the BetaFat (Beta Cell Restoration through Fat Mitigation) study, which are now published online in Diabetes Care, also showed that greater weight loss could be achieved with surgery vs metformin, with a 8.9 kg difference between the groups at 2 years (10.6 vs 1.7 kg, respectively, P < .01).

HDL cholesterol levels also rose with both interventions, and gastric banding resulted in a greater effect on very low–density lipoprotein cholesterol and triglycerides, as well as serum ALT, Dr. Buchanan said.

The BetaFat study is 1 of 3 “proof-of principle” studies currently being conducted by the RISE Consortium in patients with IGT, sometimes called prediabetes, and T2DM, explained Steven E. Kahn, MB, ChB, the chair for the RISE studies.

The other 2 multicenter, randomized trials being conducted by the RISE Consortium are looking at the effects of medications on preserving beta-cell function in pediatric/adolescent (10-19 years) and adult (21-65 years) populations with IGT or mild, recently diagnosed T2DM. The design, and some results, of these trials can be viewed on a dedicated section of the Diabetes Care website.

Beta-cell function is being assessed using “state-of-theart” methods; the coprimary endpoint of the surgery versus metformin study was the steady state C-peptide level and acute C-peptide response at maximal glycemia measured using a hyperglycemic “clamp.”

The goal of the RISE studies is to test different approaches to preserve beta-cell function. It is designed to answer the question of which is more effective in this setting: sustained weight loss through gastric banding such as in the BetaFat study or medication.

The RISE Consortium conducted the BetaFat study. The RISE Consortium is supported by grants from the National Institutes for Health. Further support came from the US Department of Veterans Affairs, Kaiser Permanente Southern California, the American Diabetes Association, and Allergan. Additional donations of supplies were provided by Allergan, Apollo Endosurgery, Abbott, and Novo Nordisk. Dr. Buchanan reported receiving research funding from Allergan and Apollo Endosurgery. Dr. Taylor had no conflicts of interest.

Sara Freeman, Clinical Endocrinology News

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