XI. STRATEGIES FOR IMPROVING DIABETES CARE D iabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3). The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E.

Standards of Medical Care in Diabetes

Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)

ContextAbout 5% of the US population is morbidly obese. This disease remains
largely refractory to diet and drug therapy, but generally responds well to
bariatric surgery.ObjectiveTo determine the impact of bariatric surgery on weight loss, operative
mortality outcome, and 4 obesity comorbidities (diabetes, hyperlipidemia,
hypertension, and obstructive sleep apnea).Data Sources and Study SelectionElectronic literature search of MEDLINE, Current Contents, and the Cochrane
Library databases plus manual reference checks of all articles on bariatric
surgery published in the English language between 1990 and 2003. Two levels
of screening were used on 2738 citations.Data ExtractionA total of 136 fully extracted studies, which included 91 overlapping
patient populations (kin studies), were included for a total of 22 094
patients. Nineteen percent of the patients were men and 72.6% were women,
with a mean age of 39 years (range, 16-64 years). Sex was not reported for
1537 patients (8%). The baseline mean body mass index for 16 944 patients
was 46.9 (range, 32.3-68.8).Data SynthesisA random effects model was used in the meta-analysis. The mean (95%
confidence interval) percentage of excess weight loss was 61.2% (58.1%-64.4%)
for all patients; 47.5% (40.7%-54.2%) for patients who underwent gastric banding;
61.6% (56.7%-66.5%), gastric bypass; 68.2% (61.5%-74.8%), gastroplasty; and
70.1% (66.3%-73.9%), biliopancreatic diversion or duodenal switch. Operative
mortality (≤30 days) in the extracted studies was 0.1% for the purely restrictive
procedures, 0.5% for gastric bypass, and 1.1% for biliopancreatic diversion
or duodenal switch. Diabetes was completely resolved in 76.8% of patients
and resolved or improved in 86.0%. Hyperlipidemia improved in 70% or more
of patients. Hypertension was resolved in 61.7% of patients and resolved or
improved in 78.5%. Obstructive sleep apnea was resolved in 85.7% of patients
and was resolved or improved in 83.6% of patients.ConclusionsEffective weight loss was achieved in morbidly obese patients after
undergoing bariatric surgery. A substantial majority of patients with diabetes,
hyperlipidemia, hypertension, and obstructive sleep apnea experienced complete
resolution or improvement.

https://jamanetwork.com/journals/jama/articlepdf/199587/JRV40082.pdf

Bariatric surgery: a systematic review and meta-analysis.

Context.—Observational studies have found lower rates of coronary heart disease
(CHD) in postmenopausal women who take estrogen than in women who do not,
but this potential benefit has not been confirmed in clinical trials.Objective.—To determine if estrogen plus progestin therapy alters the risk for
CHD events in postmenopausal women with established coronary disease.Design.—Randomized, blinded, placebo-controlled secondary prevention trial.Setting.—Outpatient and community settings at 20 US clinical centers.Participants.—A total of 2763 women with coronary disease, younger than 80 years,
and postmenopausal with an intact uterus. Mean age was 66.7 years.Intervention.—Either 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone
acetate in 1 tablet daily (n=1380) or a placebo of identical appearance (n=1383).
Follow-up averaged 4.1 years; 82% of those assigned to hormone treatment were
taking it at the end of 1 year, and 75% at the end of 3 years.Main Outcome Measures.—The primary outcome was the occurrence of nonfatal myocardial infarction
(MI) or CHD death. Secondary cardiovascular outcomes included coronary revascularization,
unstable angina, congestive heart failure, resuscitated cardiac arrest, stroke
or transient ischemic attack, and peripheral arterial disease. All-cause mortality
was also considered.Results.—Overall, there were no significant differences between groups in the
primary outcome or in any of the secondary cardiovascular outcomes: 172 women
in the hormone group and 176 women in the placebo group had MI or CHD death
(relative hazard [RH], 0.99; 95% confidence interval [CI], 0.80-1.22). The
lack of an overall effect occurred despite a net 11% lower low-density lipoprotein
cholesterol level and 10% higher high-density lipoprotein cholesterol level
in the hormone group compared with the placebo group (each P<.001). Within the overall null effect, there was a statistically
significant time trend, with more CHD events in the hormone group than in
the placebo group in year 1 and fewer in years 4 and 5. More women in the
hormone group than in the placebo group experienced venous thromboembolic
events (34 vs 12; RH, 2.89; 95% CI, 1.50-5.58) and gallbladder disease (84
vs 62; RH, 1.38; 95% CI, 1.00-1.92). There were no significant differences
in several other end points for which power was limited, including fracture,
cancer, and total mortality (131 vs 123 deaths; RH, 1.08; 95% CI, 0.84-1.38).Conclusions.—During an average follow-up of 4.1 years, treatment with oral conjugated
equine estrogen plus medroxyprogesterone acetate did not reduce the overall
rate of CHD events in postmenopausal women with established coronary disease.
The treatment did increase the rate of thromboembolic events and gallbladder
disease. Based on the finding of no overall cardiovascular benefit and a pattern
of early increase in risk of CHD events, we do not recommend starting this
treatment for the purpose of secondary prevention of CHD. However, given the
favorable pattern of CHD events after several years of therapy, it could be
appropriate for women already receiving this treatment to continue.

https://jamanetwork.com/journals/jama/articlepdf/187879/JOC80678.pdf

Randomized Trial of Estrogen Plus Progestin for Secondary Prevention of Coronary Heart Disease in Postmenopausal Women

The metabolic syndrome

Metabolic/Bariatric Surgery Therapy for the Metabolic Syndrome

Surgical treatment of hyperlipidemia. II. The laboratory experience.

An orthopedic catheter for long-term access to the synovial joint is anchored by a hollow threaded tap that penetrates the capsule through a hole drilled in the surrounding bone. The proximal end of the catheter is connected to either an implantable drug infusion pump or an implantable access port for continuous or intermittent perfusion or sampling. Four catheters were evaluated in dogs. Three were attached to ports, the fourth to a pump. Water (one trial, 22 weeks) and hyaluronic acid (HA) (5 mg/ml; two trials of 8 weeks each) were administered through ports twice weekly in 1.5 ml boluses; 5 mg/ml HA was delivered by pump (1 trial of 33 weeks) at 0.31 ml/day.

Catheter with an anchoring tip for chronic joint capsule perfusion.

The Program on the Surgical Control of the Hyperlipidemias (POSCH), a randomized clinical trial, tested the hypothesis that cholesterol modification induced by partial ileal bypass would favorably affect mortality and morbidity due to coronary heart disease (CHD). The study population consisted of 838 patients (417 in the control group and 421 in the surgery group) in four clinical centers, both men (90.7%) and women with an average age of 51 years who had survived a first myocardial infarction. The lipid changes in POSCH have been the most marked in any atherosclerosis intervention trial utilizing a single mode of intervention in addition to diet therapy. At 5 years, the surgery group, compared with the control group, had a 23.3 ± 1.0% (mean ± SE) lower total plasma cholesterol level (p < 0.0001), a 37.7 ± 1.2% lower low-density lipoprotein cholesterol level (p < 0.0001), and a 4.3 ± 1.8% higher high-density lipoprotein cholesterol level (p = 0.02). For the combined end point of CHD mortality and confirmed nonfatal myocardial infarction, there was a 35.0% reduction in the surgery group (p < 0.001). Coronary artery bypass grafting was reduced in the surgery group by 62.0% (p < 0.0001) and percutaneous transluminal coronary angioplasty was reduced by 55.0% (p < 0.01). A comparison of baseline coronary arteriograms with those obtained at 3, 5, 7, and 10 years consistently showed less atherosclerosis disease progression (p < 0.001) and greater atherosclerosis disease regression at 5 and 7 years (p < 0.01) in the surgery group. At formal trial completion in July 1990, the overall mortality in the surgery subgroup with an ejection fraction of 50% or greater was 36.1% lower (p = 0.02). During subsequent follow-up, trends toward statistical significance for differences in both CHD and in overall mortality have become evident. The POSCH results provide strong support for beneficial clinical and arteriographic reduction of atherosclerosis progression after lipid modification by partial ileal bypass.

Henry Buchwald

Papers

Metabolic/Bariatric Surgery Therapy for the Metabolic Syndrome

Surgical treatment of hyperlipidemia. II. The laboratory experience.

Catheter with an anchoring tip for chronic joint capsule perfusion.

Program on the surgical control of the hyperlipidemias: 1994 report

Use of polyethylene-lined silicone rubber cannulae in long-term insulin infusion in the dog.