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Treatment of Type 2 Diabetes: From "Guidelines" to "Position Statements" and Back: Recommendations of the Israel National Diabetes Council

Ofri Mosenzon
Aug 1, 2016; 39:S146-S153
II. Diabetes Treatment Options




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2019 Update to: Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

John B. Buse
Feb 1, 2020; 43:487-493
Consensus Report Update




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Redefining Hypoglycemia in Clinical Trials: Validation of Definitions Recently Adopted by the American Diabetes Association/European Association for the Study of Diabetes

OBJECTIVE

To determine if the International Hypoglycaemia Study Group (IHSG) level 2 low glucose definition can identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials.

RESEARCH DESIGN AND METHODS

A post hoc analysis was performed of the SWITCH (SWITCH 1: n = 501, type 1 diabetes; SWITCH 2: n = 721, type 2 diabetes) and DEVOTE (n = 7,637, type 2 diabetes) trials utilizing the IHSG low glucose definitions. Patients in all trials were randomized to either insulin degludec or insulin glargine 100 units/mL. In the main analysis, the following definitions were compared: 1) American Diabetes Association (ADA) 2005 (plasma glucose [PG] confirmed ≤3.9 mmol/L with symptoms); and 2) IHSG level 2 (PG confirmed <3.0 mmol/L, independent of symptoms).

RESULTS

In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed. Similar results were observed for the SWITCH 1 trial. In SWITCH 2, the IHSG level 2 definition produced a rate ratio that was lower than the ADA 2005 definition.

CONCLUSIONS

The IHSG level 2 definition was validated in a series of clinical trials, demonstrating its ability to discriminate between basal insulins. This definition is therefore recommended to be uniformly adopted by regulatory bodies and used in future clinical trials.




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A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

OBJECTIVE

Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.

RESEARCH DESIGN AND METHODS

Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy—both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.

RESULTS

At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P = 0.013).

CONCLUSIONS

This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.




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Respective Contributions of Glycemic Variability and Mean Daily Glucose as Predictors of Hypoglycemia in Type 1 Diabetes: Are They Equivalent?

OBJECTIVE

To evaluate the respective contributions of short-term glycemic variability and mean daily glucose (MDG) concentration to the risk of hypoglycemia in type 1 diabetes.

RESEARCH DESIGN AND METHODS

People with type 1 diabetes (n = 100) investigated at the University Hospital of Montpellier (France) underwent continuous glucose monitoring (CGM) on two consecutive days, providing a total of 200 24-h glycemic profiles. The following parameters were computed: MDG concentration, within-day glycemic variability (coefficient of variation for glucose [%CV]), and risk of hypoglycemia (presented as the percentage of time spent below three glycemic thresholds: 3.9, 3.45, and 3.0 mmol/L).

RESULTS

MDG was significantly higher, and %CV significantly lower (both P < 0.001), when comparing the 24-h glycemic profiles according to whether no time or a certain duration of time was spent below the thresholds. Univariate regression analyses showed that MDG and %CV were the two explanatory variables that entered the model with the outcome variable (time spent below the thresholds). The classification and regression tree procedure indicated that the predominant predictor for hypoglycemia was %CV when the threshold was 3.0 mmol/L. In people with mean glucose ≤7.8 mmol/L, the time spent below 3.0 mmol/L was shortest (P < 0.001) when %CV was below 34%.

CONCLUSIONS

In type 1 diabetes, short-term glycemic variability relative to mean glucose (i.e., %CV) explains more hypoglycemia than does mean glucose alone when the glucose threshold is 3.0 mmol/L. Minimizing the risk of hypoglycemia requires a %CV below 34%.




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European Immigrants in the United States

European immigrants in the United States have largely dwindled in number since 1960, after historically making up the bulk of immigration to the country. Today, immigrants from Eastern Europe account for the largest share of European arrivals, and Europeans overall are much older and more educated than the total foreign- and native-born populations. This article explores the data on Europeans in the United States.




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Caribbean Immigrants in the United States

Caribbean immigrants represent 10 percent of the 44.5 million immigrants in the United States, with the vast majority coming from just five countries: Cuba, the Dominican Republic, Jamaica, Haiti, and Trinidad and Tobago. Depending on their origin country and period of arrival, immigrants from the Caribbean have varying skill levels, racial composition, language background, and motivations for migration, as this article explores.




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Korean Immigrants in the United States

Approximately 1 million Korean immigrants—the vast majority from South Korea—resided in the United States in 2017. Korean immigrants tend to be highly educated and of high socioeconomic standing. Get the latest data on this population, including flows over time, geographic distribution, employment, and more in this Spotlight.




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Amid an Unfolding Humanitarian Crisis in Syria, the European Union Faces the Perils of Devolving Migration Management to Turkey

The high-stakes gambit taken by Turkish President Recep Tayyip Erdoğan to allow tens of thousands of asylum seekers and migrants free movement to the Greek border demonstrated the fragility of the EU-Turkey deal and the European Union's broader approach to outsource migration management to third countries. This article examines the causes for the tensions, the EU approach to external partnerships, and a hardening European attitude towards unwanted arrivals.




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USCIS Fee Increase Proposed Rule Could Represent the Latest Step in Reshaping Immigration to United States

While much attention has been given to the move by U.S. Citizenship and Immigration Services to raise its application fees—including an 83 percent hike to apply for U.S. citizenship—the policy changes embedded in the proposed rule have been less scrutinized. The changes, including the elimination of most fee waivers for lower-income applicants, would likely reduce the number and shift the profile of those getting a green card or other immigration status.




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Coronavirus Is Spreading across Borders, But It Is Not a Migration Problem

Travel bans, border closures, and other migration management tools did not prove effective at blocking COVID-19 from spreading across international borders. Yet as governments have shifted from containment to mitigation with the coronavirus now in community transmission in many countries, these restrictions are a logical part of the policy toolkit in the context of social distancing and restricting all forms of human movement, as this commentary explores.




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Will Supreme Court Ruling on DACA Finally Force Congress to Break the Ice on Immigration Reform?

The fate of the Deferred Action for Childhood Arrivals (DACA) program has ping ponged between all three branches of government. But with the Supreme Court poised to decide DACA's future in spring 2020, Congress may finally be forced to act to resolve the status of DREAMers after nearly two decades of considering various DREAM Act bills. Could this break the long stalemate Congress has had on passing substantive immigration legislation, and pave the way for other actions?




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HHS releases video tutorial for searching list of excluded individuals/entities

The Department of Health and Human Services released Nov. 25 a five-minute video explaining how to search its list of excluded individuals and entities, called LEIE.




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Dental schools, industry team up to create innovation centers

The Center for Research & Education in Technology is encouraging dental schools to find out how to participate in its program and learn about the benefits to the school and its students.




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ADA standard on treating biofilm in waterlines available for comment

The American Dental Association Standards Committee on Dental Products has approved the document for circulation and comment.




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Dental sealant webinar to stream Feb. 6

The ADA will present a free webinar Feb. 6 on dental sealants, especially designed to help dental providers in communities that do not yet have sealant programs in place.




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Arizona Mission of Mercy event provides treatment to over 1,700

The Central Arizona Dental Society hosted a Mission of Mercy event Dec. 13-14 at the Arizona State Fairgrounds in Phoenix, providing treatment to 1,785 patients totaling just over $2 million in free dental service.




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2019 marks big year for Washington office

The Association’s Washington office covered a wide range of advocacy issues in 2019 — from vaping to student loan reform to making sure dentistry was exempt from the U.S. Mexico-Tourism Act.




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February JADA examines connection between healthy eating habits, untreated caries

Greater compliance with dietary guidelines may reduce the chance of untreated caries in adults, according to a study published in the February issue of The Journal of the American Dental Association.




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‘It’s very rewarding when dentists can treat veterans’

“Our nation’s veterans deserve the best.” Those were the words of ADA President Chad P. Gehani following his Jan. 7 visit to the Orlando VA Healthcare System’s dental clinic.




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Scholarship applicants sought for 2020 Institute for Teaching and Learning

This year’s Institute for Teaching Learning program is scheduled for Aug. 23-26 in Atlanta. Now in its 14th year, with over 700 alumni, the program combines presentations, discussions, small group activities and peer-to-peer learnings to give participants new teaching skills. The onsite program is followed by a six-month distance learning experience that include online activities and interactive webinars.




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National Children’s Dental Health Month highlights optimally fluoridated water

This year the February observance of National Children’s Dental Health Month honors the 75th anniversary of community water fluoridation with its theme, “Fluoride in water prevents cavities! Get it from the tap!”




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Dental Quality Alliance to help dentists make connection between everyday dentistry, quality measures

The Dental Quality Alliance will help dentists learn more about how quality measure domains can be best used to drive quality improvement at the practice level through a free webinar in March.




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Addressing caries through the lens of social justice, health equity, human rights

It’s a conviction that was published in the November issue of The Journal of the American Dental Association and the basis for the October 2019 forum that Dr. Francisco Ramos-Gomez fostered, where dentists, physicians, nurses and public health and public policy experts proposed, discussed and recommended solutions for preventing early childhood caries through the lens of social justice, health equity and human rights.




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Dental service leaders visit Washington

Dental service leaders met with the ADA Council on Government Affairs Jan. 25 in Washington to discuss legislative and regulatory issues.




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Indian Health Service honoring National Children’s Dental Health Month

The Indian Health Service is presenting a four-part series of messages focused on their younger patients’ oral heath in honor of the February observance of National Children’s Dental Health Month.




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HIPAA fee limitation no longer applies to third-party access to health records

Following a ruling in federal court two days prior, the Department of Health and Human Services announced Jan. 25 that the Health Insurance Portability and Accountability Act Privacy Rule fee limitations do not apply to requests to transmit copies of records to third-parties.




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After 3 years, Find-a-Dentist initiative a ‘success’

Of the more than 3 million profile views, the program found that 17% resulted in action, which include potential patients visiting a dentist’s website, calling or emailing the practice and sharing their profile. Industry average for similar sites is only 1-4%, so patients are nearly six times more likely to contact an ADA dentist through Find-a-Dentist.




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Journal of Public Health Dentistry study finds association between man-made chemical, childhood caries

Circulating levels of perfluorodecanoic acid, a type of perfluoroalkyl acid, may be associated with dental caries in children, according to a study published in the fall 2019 issue of the Journal of Public Health Dentistry.




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New dentists, ADA officers and Board members meet Feb. 9 to exchange ideas

Dr. Emily Mattingly, chair, New Dentist Committee, 6th District, shares her experience as a new dentist in a rural Missouri town. Three other NDC members also shared new dentist perspectives.




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Abstract deadline for smokeless tobacco summit at end of February

The deadline for abstracts for the upcoming National Summit on Smokeless Tobacco Prevention is Feb. 29.




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World Oral Health Day calls for pledges to show unity

Pledge to celebrate World Oral Health Day on March 20 with the rest of the sphere.




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Indian Health Service, ADA collaborate on Give Kids A Smile for first time

It was a Give Kids A Smile event not only for the children of the Mississippi Band of Choctaw Indians but also no fewer than 117 Indian Health Service dental programs across 24 states that were participating in GKAS with the events alone estimated to involve 14,000 American Indian/Alaska Native children.




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NIDCR seeks comments on research proposal

The National Institute of Dental and Craniofacial Research is seeking comments on a proposed research initiative on dental fear and anxiety.




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March JADA finds past incarceration associated with oral health issues

Formerly incarcerated people in the U.S. have worse oral health outcomes than those who have never been in prison, according to a study published in the March issue of The Journal of the American Dental Association.




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ADA releases coronavirus handout for dentists based on CDC guidelines

The handout covers strategies for helping prevent the transmission of suspected respiratory disease in the dental health care setting and answers frequently asked questions related to the virus, based on guidelines from the Centers for Disease Control and Prevention.




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American Institute of Dental Public Health mentors next generation of service-oriented dentists

Dr. David P. Cappelli, Ph.D., acknowledges that as providers, we don’t often understand difficulties that some patients face to receive needed dental care.




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FDI World Dental Congress abstract deadline in late March

The deadline for submission of abstracts for the FDI World Dental Congress is March 25.




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Learning, social opportunities abound at ADA FDC 2020

Registration opens April 22 for the ADA FDC Annual Meeting, which will offer a variety of learning and social opportunities for dentists and their teams to enjoy.




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Tampa Bay Lightning team dentist puts players’ mouths back together again

When Dr. Gil Rivera became a dentist, he had no idea his career would take him to the bloodied and bruised front lines of the NHL, but nearly 18 years later, he continues to treat the ravaged mouths of professional hockey players as the team dentist of the Tampa Bay Lightning.




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Organized dentistry supports oral health literacy

The Organized Dentistry Coalition is applauding Congress for introducing legislation aimed at improving oral health literacy.




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ADA to stream dental insurance webinar in April

Trying to navigate the world of dental benefits can be full of choppy seas, and the ADA is holding a free webinar in April to help dentists and their staff find a safe harbor full of information.




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New compendium summarizes best practices in oral health service delivery

Titled “Compendium of Innovations in Oral Health Service Delivery,” the 64-page digital booklet features organizations from across the country that have found success through varied measures in expanding oral care to underserved populations.




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Study: Dental fluorosis generally less noticeable over time

Results from a University of Iowa College of Dentistry study suggest that mild and moderate dental fluorosis is generally less noticeable over time, validating the beliefs of some supporters of community water fluoridation that there have been overestimates of fluorosis prevalence made by anti-fluoridation activists.




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Illinois orthodontist wins ADA Stanford Award for retainer research

An Illinois orthodontist won the American Dental Association's 2019 John W. Stanford New Investigator Award for her research paper evaluating the effects of eight cleaning methods on copolyester polymer, a material commonly used in clear thermoplastic retainers.




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ADEA cancels annual session due to coronavirus concerns

The American Dental Education Association announced March 9 it has cancelled its annual session due to the coronavirus disease, now named COVID-19.




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Connecticut Foundation for Dental Outreach postpones Mission of Mercy dental clinic amid coronavirus concerns

The Connecticut Foundation for Dental Outreach has postponed the Connecticut Mission of Mercy Free Dental Clinic scheduled for March 20-21 in Danbury, Connecticut, "out of abundant caution" amid the coronavirus disease outbreak.




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Association launches new ADA Science & Research Institute

The American Dental Association launched the new ADA Science & Research Institute LLC on Jan. 1, bringing together the Science Institute in Chicago and research group in Gaithersburg, Maryland, that previously reported to the ADA Foundation.




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Treasury, IRS delay federal tax filing, payments until July 15

Taxpayers do not need to file or pay their federal income taxes until July 15, after the U.S. Department of the Treasury and Internal Revenue Service extended both deadlines from April 15.




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ADA urges Congress to increase relief for small businesses, dentist owners

As Congress works on a third legislation package in response to the coronavirus pandemic, the ADA is asking lawmakers to include provisions on how to assist dental practices and other small businesses facing economic burdens.