Charles Bankhead

From the American Association of Diabetes Educators

     Los Angeles&#8212;Use of a      transcutaneous 7-day continuous blood glucose monitor led to significant      improvements in the glycemic profile of both poorly controlled and      well-controlled patients with diabetes, according to data reported at the      American Association of Diabetes Educators annual meeting.  

     After a 3-week trial of the STS Continuous Glucose      Monitoring System, a continuous glucose monitor, patients with poor      glycemic control had reduced mean glucose levels and improved target-range      glycemia, without any increase in hypoglycemic episodes. Well-controlled      patients maintained the time spent in the target range for glycemia, but      experienced significantly less hypoglycemia.  

     &#8220;As patients start to see the data, they can      make more intelligent decisions,&#8221; said Howard C. Zisser, MD, director      of clinical research at the Sansum Diabetes Research Institute in Santa      Barbara, Calif. &#8220;By the end of the study, patients were dampening the      [blood glucose] highs and dampening the lows.&#8221;  

     The findings are from a study of 86 insulin-requiring      patients: 69 with type 1 diabetes and 17 with type 2 diabetes. Of these      patients, 12 had poorly controlled diabetes, defined as hemoglobin      (Hb) A

 ≤7%); and the remainder had intermediate glycemic      control.   

     Each patient used the STS monitor for 3      consecutive 7-day monitoring periods. The system includes a glucose sensor      that is inserted into the abdomen and measures and reports glucose values      every 5 minutes. The device is equipped with a programmable alarm to alert      of blood glucose fluctuations.   

     Dr Zisser noted that the STS monitor is currently      approved for 72 hours of use per sensor, and the 7-day sensor is now in      clinical studies.   

     Patients inserted the sensors under the supervision of      clinical staff and then used the device at home or at work. The monitor      provided information on 1-, 3-, and 9-hour blood glucose trends and was      programmed to provide an alert if levels fell to <80 mg/dL and to sound      a hypoglycemia alarm if they fell to <55 mg/dL.  

     During the first monitoring period, patients were      blinded to the results. During the second and third periods, they used the      monitor as an adjunct to diabetes self-management.   

     Comparison of the blinded and unblinded monitoring      periods revealed significant improvements in glycemic      control among all patients, including those with poorly      controlled glucose levels (Table).   

     Patients with good control at baseline had a      significant 46.4% decrease in time spent in the hypoglycemic range.  

     The 4 adverse events reported during the study were not      considered serious or device related. No sensor-related infections or      hypoglycemic events requiring third-party intervention were reported.  

     &#8220;Sometimes with therapy, you can decrease the      highs but also increase the lows,&#8221; said Dr Zisser. &#8220;As HbA

 gets better, the risk of      severe hypoglycemia may increase. Because of the ability to set alarms      and identify trend setting, patients can decrease hyperglycemia and      decrease hypoglycemia, allowing them to spend more time in the normal      range.&#8221;  

Articles

7-Day Continuous Monitoring Improves Glycemic Control

Prediabetes Surprisingly Associated with Increased      Levels of Depression  

     Los Angeles&#8212;Patients      who have recently progressed from a high-risk cardiometabolic state to type      2 diabetes appear to have fewer depressive symptoms, which can make them      more receptive to interventions that encourage self-management of their      disease, survey results presented at the American Association of Diabetes      Educators meeting indicate.  

     Patients with ≥3 risk factors for      diabetes had higher levels of depression than they did after they      progressed to type 2 diabetes.   

     The reason for this unexpected finding is unclear,      but investigators speculated that some high-risk patients might be relieved      to find that their symptoms have an identifiable and treatable cause.  

     &#8220;What this survey indicates is that possibly we      have a very narrow window of time of diagnosis when the level of depression      declines, and maybe we&#8217;ll be more successful at changing long-term      behavior,&#8221; said Debbra Bazata, RD, a diabetes educator with St.      Luke&#8217;s South Primary Care in Overland Park, Kan.  

     Depression increases a person&#8217;s risk of      developing type 2 diabetes, and the prevalence of depression in patients      with diabetes is higher than their nondiabetic counterparts.   

     However, little information was available on levels      of depression in high-risk patients immediately before and just after they      meet the criteria for diabetes.  

     The Study to Help Improve Early Evaluation and      Management of Risk Factors Leading to Diabetes (SHIELD) examined depression      in 11,088 persons with self-reported diabetes or risk factors for the      condition, such as abdominal obesity, dyslipidemia, or hypertension. The      study population was selected from returned questionnaires that were      mailed to a random sample. Depression was assessed by a 9-item survey      instrument. Participants completed the questionnaires at entry and again 1      year later.  

     Patients with ≤2 diabetes risk factors were classified as low risk; those      with ≥3 risk factors were high risk. Survey respondents were      categorized according to their risk transition over the course of the study      (ie, low to high risk, high risk to type 2 diabetes, and high to low risk).       

     At baseline and at follow-up, high-risk patients and      those with type 2 diabetes were more likely to have moderate or severe      depression compared with those at low risk.   

     The odds for moderate depression was 31% greater in      high-risk patients and 55% greater in patients with type 2 diabetes. Severe      depression was 52% more likely in high-risk patients and 82% more likely in      patients with type 2 diabetes.  

     The prevalence of major depression decreased from 11%      at baseline to 7% at 12 months in patients who went from high risk to low      risk for diabetes. Unexpectedly, among patients who progressed from high      risk to type 2 diabetes, the prevalence of major depression also decreased      from 11% to 7%.   

     In patients whose diabetes risk status did not change      or who progressed from low risk to diabetes, little or no change was seen      in depression prevalence.  

     These results show that the relationship between      diabetes and depression is complex, said Ms Bazata. For example, being in a      high-risk transition group had the strongest influence on the level of      depression between baseline and 12 months. However, levels of depression      were also more likely to decrease among high-risk transition groups during      follow-up.  

     One potential implication of these findings is that      diagnosis and treatment of depression in patients at high risk for diabetes      might have a favorable impact on their receptivity and adherence to      interventions aimed at improving diabetes self-management.  

     &#8220;There&#8217;s no question that patients who      are depressed have more difficulty adhering to interventions,&#8221; said      Ms Bazata. &#8220;Mental health is a big issue in a patient&#8217;s ability      to make behavior change, and attention to that issue could be      helpful.&#8221;   

Optimize Depression Therapy in Patients at Risk for Diabetes

     Los Angeles?Despite a large volume of circumstantial evidence,      modulation of the renin-angiotensin system (RAS) as a means of preventing      diabetes requires further study, especially      clinical trials that have diabetes as a primary end point.?  

     Interpretation or      extrapolation of the current data on the issue has to be done with      caution, said Laura Shane-McWhorter, PharmD, of the      ?University of Utah Health Sciences Center, at the American Association of Diabetes Educators meeting. Most of the data collected to date have come from      unplanned, post hoc analyses. In addition, the definition of diabetes      has varied among the studies.  

     "Depending on when the study was published, the      criteria for diagnosing diabetes was different," she said.      "Earlier studies used the old definition of greater than 140 [mg/dL].      Newer studies used the current definition of higher than 126. Another issue      relates to use of other medications. Was the result for these      renin-angiotensin system modulators positive because you have negative      effects with diuretics and beta-blockers, which tend to adversely affect      blood glucose? What about the role of calcium channel blockers? It turns      out that calcium channel blockers have some benefits. In some of the      trials, patients might have been on concomitant calcium channel      blockers."   

     The recent publication of DREAM (Diabetes      Reduction Assessment with Ramipril and Rosiglitazone Medication) study      (

.      2006; 355:1551-1562) showed that treatment with      the angiotensin-converting-enzyme?(ACE)      inhibitor ramipril did not reduce the risk of new-onset diabetes in      patients with impaired fasting glucose or impaired glucose tolerance (IGT).      However, ramipril significantly increased the rate of regression to      normoglycemia compared with placebo.  

     The search for strategies to prevent diabetes has been      going on for at least 2 decades. One study showed that a combination of      diet and exercise reduced the incidence of diabetes by 42% over 6 years      compared with a control in 577 patients with IGT (

. 1997; 20:537-544). A      few years later, Finnish investigators reported a 58% reduction in diabetes      incidence over 4 years in middle-aged patients with IGT who were randomized      to lifestyle interventions (

     The Diabetes Prevention Program trial found weight      loss and exercise to be significantly more effective than metformin for      preventing diabetes (

. 2002; 346:393-403). And troglitazone was shown to      significantly reduce the risk of diabetes compared with placebo in a group      of Hispanic women with a history of gestational diabetes (

. 2002; 51:2796-2803).      The beneficial effects appeared to be related to ameliorating insulin      resistance, which helps preserve pancreatic beta-cell function.  

     Multiple studies have yielded evidence that inhibition      of RAS with ACE inhibitors or angiotensin receptor blockers (ARBs) can      prevent diabetes in high-risk patients. The risk reduction has been      attributed to a host of potential mechanisms, which collectively point to      preservation of beta-cell function, enhancement of insulin      sensitivity, changes in microcirculation, and changes in potassium and      magnesium (

     The HOPE (Heart Outcomes Prevention Evaluation) trial      raised awareness of the possibility that treatment with an ACE inhibitor or      ARB might reduce the risk of diabetes. Patients treated with ramipril had a      34% reduction in the relative risk of diabetes compared with placebo.      Results of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent      Heart Attack Trial) showed that patients randomized to the ACE inhibitor      lisinopril had a 30% lower incidence of diabetes compared with those      treated with a diuretic and a 17% lower incidence compared with those      treated with amlodipine, a calcium channel blocker.  

     Additional studies have shown a reduced risk of      new-onset diabetes in patients treated with the ARBs losartan, valsartan,      and candesartan, with a magnitude of reduction ranging from 20% to 25% in      each trial (

.      2002; 359:995-1003, 2004; 363:2022-2031; 

     As noted by Dr Shane-McWhorter, data on the      association between RAS inhibition and reduced diabetes risk has a      number of limitations, not the least of which is the retrospective nature      of much of the information. The mixed results of the DREAM trial      underscore the need for controlled trials.  

     The ongoing NAVIGATOR (Nateglinide and Valsartan      in Impaired Glucose Tolerance Outcomes Research) trial represents a      new effort. NAVIGATOR investigators have screened 43,000 patients and have      randomized 9000 with IGT who are at high risk for cardiovascular disease.      This trial is expected to be completed in 2008.  