Clinical Audit on Hypoglycaemic Symptoms in Type 2 Diabetic Patients in SingHealth Polyclinics

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1 original article Clinical Audit on Hypoglycaemic Symptoms in Type 2 Diabetic Patients in SingHealth Polyclinics Hui Min Joanne Quah, FCFP (S), MCI (NUS), Swee Hong Stephanie Teo, BHS, MHSM, Hui Bee Gladys Yap, BB (M), Hwee Boon Lim, MMed (Family Medicine), FCFP (S), Mun Hong Chow, MMed (Family Medicine), FCFP (S) SingHealth Polyclinics, Singapore Health Services, Singapore Abstract Introduction: Hypoglycaemia is an important complication of type 2 diabetes mellitus treatment, because it causes recurrent physical and psycho-social morbidity, and it is sometimes fatal. Achieving target glycaemic goals while avoiding hypoglycaemia is a major challenge in the management of patients with type 2 diabetes mellitus. Awareness of hypoglycaemia is a function of the knowledge and experience of an individual, as well as the physiological responses to low glucose concentrations. Our team conducted an audit to identify the prevalence and underlying causes of hypoglycaemic symptoms among type 2 diabetes mellitus patients seen in SingHealth Polyclinics. This data was collected as part of our efforts to improve diabetes care and increase awareness. Methods: Audit in the form of nurse-administered interviews were carried out on 120 type 2 diabetic patients seen in the Family Physician Clinic; they were 20 consecutive patients seen in each of 6 polyclinics. The questionnaire included both patient and nurse components, identifying hypoglycaemic symptoms, causes, related hospital admissions, self-management, current treatment and control. Results: Of the 120 patients audited, 31 (26%) reported hypoglycaemic symptoms. These patients with hypoglycaemic symptoms were more likely to be on insulin treatment than those without symptoms (p=0.000). Majority of patients with symptoms did not use the glucometer when they experienced these symptoms (19/31). The cause of hypoglycaemic symptoms was often meal-related. For patients not on insulin, those with hypoglycaemic symptoms were more likely to own a glucometer than those without symptoms (p=0.033). Conclusion: Hypoglycaemia is a common complication of diabetic treatment, and efforts should be focused especially on insulin-treated patients to prevent hypoglycaemia, including education on hypoglycaemia awareness, self-monitoring of blood glucose and dietary advice. Keywords: clinical audit, diabetes mellitus type 2, hypoglycaemia, primary care, Singapore Introduction Hypoglycaemia is an important complication in the treatment of type 2 diabetes mellitus, because it causes recurrent physical and psycho-social morbidity, and is sometimes fatal 1. Achieving target glycaemic goals while avoiding hypoglycaemia is a major challenge in the management of patients with type 2 diabetes mellitus 2. Hypoglycaemia is the limiting factor in the glycaemic management of diabetes in the vast majority of people with diabetes 3,4. As a result, diabetic complications can develop or progress despite aggressive therapy. Awareness of hypoglycaemia is a function of the knowledge and experience of the individual, as well as the physiological responses to low glucose concentrations 5. The frequency of severe hypoglycaemia, hypoglycaemia requiring medical attention or admission to hospital, is higher in patients with type 2 diabetes treated with insulin compared to those on oral hypoglycaemic agents 6. Severe hypoglycaemia reported during aggressive insulin therapy of type 2 diabetes range from 3 to 73 89

2 Original Article episodes per 100 patient years 7 9. Hypoglycaemia becomes progressively more limiting to glycaemic control over time 6,10,11. Given progressive insulin deficiency in type 2 diabetes, this indicates that iatrogenic hypoglycaemia becomes a progressively more frequent clinical problem for patients with type 2 diabetes as they approach the insulindeficient end of the spectrum of type 2 diabetes 5. Known risk factors for hypoglycaemia include advanced age, multiple co-morbidities, polypharmacy ( 5 medications), chronic renal or hepatic impairment, recent hospital admission, history of hypoglycaemia, poor nutrition, use of sulfonylurea or insulin, acute illness, hypoglycaemic unawareness, and diminished counter regulatory responses 2. Self-monitoring of blood glucose is an integral component of effective diabetes management because the information obtained may be used to guide therapy, prevent hypoglycaemia, and assess the efficacy of treatment. It also serves as a useful educational tool to improve patient compliance and participation in diabetes self care 12,13. The objectives of this audit were to identify the prevalence of hypoglycaemic symptoms in SingHealth Polyclinics, as well as to identify the underlying causes for hypoglycaemic symptoms in our type 2 diabetic patients. This data was collected as part of our efforts to improve diabetes care and to increase awareness. Methods The audit was carried out in the form of nurseadministered interviews on 120 type 2 diabetic patients, from 6 polyclinics including Bedok, Bukit Merah, Marine Parade, Outram, Pasir Ris and Queenstown. Twenty consecutive diabetic patients who attended the Family Physician Clinic from each of these clinics between 10 and 15 May 2010 were audited. This was conducted as part of our clinic audit; therefore, patient consent was not required. SingHealth Polyclinics is a group of 9 primary care public polyclinics serving the eastern half of Singapore. There were a total of million medical attendances in 2010, 7.7% of these attendances for diabetes mellitus, and there are 55,000 active patients currently on our diabetes database. The Family Physician Clinic is a secondtier clinic that sees patients with chronic conditions, especially those with sub-optimal control. The questionnaire was interviewer-administered by a nurse in the language that the patient was proficient in, and consisted of 2 components the patient component and the nurse component. The patient component included demographic data, presence of hypoglycaemic symptoms including sweatiness/shivering/giddiness/hunger, frequency, time of day, relation to meals, patient s perception to cause, action taken, checking of glucose levels, as well as control including diet, exercise, oral medication, insulin, owning of a glucometer, and previous admissions for hypoglycaemia. The nurse component included the latest HbA1c level, patient s recognition of symptoms, patient s understanding of the action plan, presence of documented hypoglycaemic <3.5mmol/L, as well as causes for hypoglycaemia in the patient. Data was analysed using Pearson s chi-square test for categorical data, while continuous data were tested for normality using QQ plot, and analysed with the 2-sample t test. Results Among the 120 diabetic patients audited, 31 (26%) reported hypoglycaemic symptoms in the prior 3 months (Table 1). The average age of all patients audited was 61.9 years. There were no significant differences between patients with and without hypoglycaemic symptoms in terms of age, gender, and ethnicity, although there seemed to be a preponderance towards patients of the female gender which was not statistically significant (p=0.061). Insulin treatment was a strong predictor for patients having hypoglycaemic symptoms (p=0.000). Diabetic control was poorer in those with hypoglycaemic symptoms compared to without symptoms (HbA1c 8.4% vs 8.0%, p=0.088), although not statistically significant in this study. As a group, patients with hypoglycaemic symptoms were more likely to own a glucometer as compared to those without symptoms (71% vs 47%, p=0.029). However, when stratified according to presence of insulin treatment, for patients on insulin treatment, there was no association between hypoglycaemic symptoms and owning a glucometer (p=0.339), but for patients who were 90

3 Clinical Audit on Hypoglycemic Symptoms in Type 2 Diabetic Patients in SingHealth Polyclinics Table 1. Characteristics of diabetic patients audited. Hypoglycaemic symptoms (N=31) symptoms (N=89) P value Age in Years Mean age Age range Gender Male 11 (35%) 49 (55%) Female 20 (65%) 40 (45%) Ethnicity Chinese 17 (55%) 58 (65%) Malay 7 (22.5%) 12 (13%) Indian 7 (22.5%) 14 (16%) Others 0 (0%) 5 (6%) Insulin Treatment On insulin treatment 23 (74%) 28 (31%) Glycaemic Control HbA1c mean 8.4% 8.0% HbA1c range 5.9% 12.2% 5.1% 11.6% Own Glucometer 22 (71%) 42 (47%) (29%) 45 (51%) t known 0 (0%) 2 (2%) Stratified According to Those on Insulin: Own Glucometer 16 (70%) 22 (79%) (30%) 6 (21%) Stratified According to Those t on Insulin: Own Glucometer 6 (75%) 20 (34%) (25%) 39 (66%) Frequency of Checking Blood Sugar At least monthly 12 (39%) 24 (27%) Never to occasionally 19 (61%) 65 (73%) Stratified according to those on insulin: Frequency of checking blood sugar At least monthly 9 (39%) 13 (46%) Never to occasionally 14 (61%) 15 (54%) Stratified according to those not on insulin: Frequency of checking blood sugar At least monthly 3 (38%) 11 (18%)

4 Original Article not on insulin treatment, those who experienced hypoglycaemic symptoms were more likely to own a glucometer (p=0.033). In terms of frequency of checking blood sugar, there was no association with hypoglycaemic symptoms (p=0.219), whether or not the patient was on insulin. Among the 120 patients, 11 (9%) patients reported checking their blood glucose daily, 17 (14%) reported checking weekly, 8 (7%) reported checking monthly, 19 (16%) reported checking occasionally, 65 (54%) reported never checking or did not own a glucometer. Among the 31 patients who reported hypoglycaemic symptoms (Table 2), 29% (9/31) had documented hypoglycaemia in the previous 3 months of <3.5mmol/L, and 13% (4/31) had previously been admitted for hypoglycaemia. Majority (19/31) of the patients did not use the glucometer when they were symptomatic. Of concern is that 19% of them (6/31) experienced symptoms more than once a week. Hypoglycaemic symptoms frequently occurred before breakfast (6/31), before lunch (11/31), and the middle of the night (7/31). According to the nurses assessment, 74% (23/31) of these patients were able to recognize hypoglycaemic symptoms, and 71% (22/31) understood the action plan. Causes of hypoglycaemic symptoms were often meal related, including skipped meal/interval of meals (18/31), no night snack (7/31), insulin injection without food (5/13) and non-compliance to diet (4/31). Other causes include previous non-compliance but now compliant to medication (8/31), acute illness (5/31), poor understanding of diabetes mellitus (5/31), increased medication or insulin regime (3/31), and alcohol consumption (1/31). Discussion Hypoglycaemia is a serious complication of diabetes mellitus treatment. It is often iatrogenic and is potentially preventable. Primum non nocere, or non-maleficence, is one of the basic principles of medical ethics, to first do no harm is our core objective in the management of all patients. Despite this, one quarter of the diabetic patients in this audit experienced hypoglycaemic symptoms. This shows that hypoglycaemia is an important problem that should be explored and addressed. The clinical approach to minimising hypoglycaemia while improving glycaemic control includes: addressing the issue; applying the principles of aggressive glycaemic therapy; and considering the risk factors for iatrogenic hypoglycaemia. The principles of aggressive glycaemic therapy include 1 : patient education and empowerment; frequent self monitoring of blood glucose; flexible insulin and other drug regimens; individualised glycaemic goals; and ongoing professional guidance and support. The majority of diabetics with hypoglycaemic symptoms were patients on insulin treatment in contrast to those on oral medication or diet control. These insulin-treated patients are at a higher risk of hypoglycaemia, and hence efforts should be focused on reducing the risk in these patients. Careful selection of patients with indications for starting insulin treatment, judicious tailoring of insulin treatment regime especially when increasing the dosage, patient education on selfmanagement in terms of diet, exercise, compliance to medication and insulin, education on types and amounts and regularity of food, the importance of self-monitoring of blood glucose, as well as hypoglycaemia awareness and action plan, should be incorporated in the management of every insulin-treated patient. Fifty-three per cent (64/120) of the diabetic patients surveyed reported that they owned a glucometer. It is important to note that these patients were recruited from the Family Physician Clinic, which is a second tier clinic. The ownership of glucometers among diabetic patients in the general clinic may be different and the profile of these patients may not be the same. For diabetic patients not on insulin, those with hypoglycaemic symptoms were more likely to own 92

5 Clinical Audit on Hypoglycemic Symptoms in Type 2 Diabetic Patients in SingHealth Polyclinics Table 2: Characteristics of subset of diabetic patients with hypoglycaemic symptoms. 1. Uses glucometer when symptomatic Number of patients (Total N= 31) Percentage 8 26% 19 61% response 4 13% 2. Has documented hypoglycaemia in the last 3 months 9 29% 22 71% 3. Previous admission for hypoglycaemia 4 13% 27 87% 4. Frequency of symptoms Once in the last 3 months 9 29% Twice in 3 months 9 29% Up to once a month 3 10% Up to once a week 4 13% More than once a week 6 19% 5. Time of symptoms in relation to meals Before breakfast 6 19% Before lunch 11 35% Before dinner 5 16% Middle of the night 7 23% Others 5 16% 6. Ability to recognize symptoms 23 74% 4 13% t sure 4 13% 7. Understands action plan 22 71% 5 16% t sure 4 13% 8. Causes of hypoglycemic symptoms according to nurse s assessment Skipped meal/ Interval of meals 18 58% Previously non-compliant, now compliant 8 26% night snack 7 23% Acute illness 5 16% Insulin injection without food 5 16% Poor understanding of diabetes mellitus 5 16% n-compliance to diet 4 13% Increase medication or insulin regime 3 10% Alcohol consumption 1 3% 93

6 Original Article a glucometer than those without symptoms. This could be because these patients are more aware of their condition and the risk of hypoglycaemia, and hence bought the glucometer. It is interesting that in this audit, patients with hypoglycaemic symptoms did not check their blood sugar levels more often than those without symptoms. Among patients on insulin, 75% (38/51) own a glucometer, but only 43% (22/51) checked their blood sugar at least monthly. Also, among patients who experienced hypoglycaemic symptoms, only 26% (8/31) used their glucometer when symptomatic. According to the American Diabetes Association guidelines, self-monitoring of blood glucose should be carried out 3 or more times daily for patients using multiple insulin injections. For patients using less frequent insulin injections, non-insulin therapies, or medical nutrition therapy alone, selfmonitoring of blood glucose may be useful as a guide to the success of therapy 14. The Singapore Clinical Practice Guidelines on Diabetes Mellitus published by the Ministry of Health states that for insulin-treated type 2 diabetic patients, testing 2 or 3 times a day on 2 to 3 days a week would be appropriate15. This shows that we need to continue to encourage diabetic patients, especially those on insulin to obtain a glucometer, as well as check their blood sugar regularly and when symptomatic. It is reassuring to know that the majority of the patients are able to recognise hypoglycaemic symptoms, as well as understand the hypoglycaemia action plan. This can be attributed to the good work of the polyclinic team in continual patient education. This can still be improved so that all patients can benefit and achieve optimal diabetic control. It is interesting that patients who experienced hypoglycaemic symptoms had poorer glycaemic control as measured by the HbA1c. Although this did not reach significance, it highlights to us that tighter diabetic control is important, so as to ensure that glucose levels do not swing to the extremes, and predispose the patient to hyper- and hypoglycaemia. Larger studies can be conducted to investigate this phenomenon. The cause of hypoglycaemic symptoms in this audit were most commonly meal-related, due to skipped meal or varying intervals of meals, lack of night snack, insulin injection without food and non-compliance to diabetic diet. This reinforces the importance of education on the diabetic diet, not just in terms of type and quantity of food, but also the interval and consistency of meals, in relation to their medication and insulin treatment. Education is the key to preventing recurrent or severe hypoglycaemia. As such, there should be close co-ordination of care between the patient, physician and all other healthcare providers in identifying the cause of hypoglycaemia, and appropriate steps should be taken to prevent further episodes. Prevention of hypoglycaemia has the potential to improve psychosocial aspects of health, including enhanced quality of life, boosted confidence, improved compliance with diabetic regimens and avoidance of long term complications 2. The limitations of this audit include its small sample size, and hence higher powered studies can be conducted to explore the associations seen here. It was conducted as a cross-sectional audit, which is only able to detect associations but not causation. Longitudinal studies could be done to study this topic further. We used the clinical symptoms of sweatiness, shivering, giddiness and hunger to detect hypoglycaemic episodes. This is because our team aimed to understand the burden of hypoglycaemic symptoms among our diabetic patients. On the other hand, collecting information solely on documented hypoglycaemia would not be accurate because a large proportion of type 2 diabetic patients do not own a glucometer or do not check home sugar monitoring. Strengths of the audit are that there were both patient and nurse input, where the nurse was part of the managing team involved in the patient care that was familiar with the patient s condition and was able to report accurate information. Conclusion Hypoglycaemic symptoms are a common complication of diabetic treatment, and efforts should be focused especially on insulin-treated patients to prevent hypoglycaemia, including education on hypoglycaemia awareness, selfmonitoring of blood glucose and dietary advice. 94

7 Clinical Audit on Hypoglycemic Symptoms in Type 2 Diabetic Patients in SingHealth Polyclinics References 1. Cryer PE. Hypoglycaemia: Pathophysiology, Diagnosis and Treatment. 1st ed. New York, NY: Oxford University Press p. 2. Chelliah A, Burge MR. Hypoglycaemia in elderly patients with diabetes mellitus: causes and strategies for prevention. Drugs Aging. 2004;21(8): The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med Sep 30;329(14): Haffner S, Temprosa M, Crandall J, Fowler S, Goldberg R, Horton E, et al. Intensive lifestyle intervention or metformin on inflammation and coagulation in participants with impaired glucose tolerance. Diabetes May;54(5): Cryer PE, Davis SN, Shamoon H. Hypoglycaemia in diabetes. Diabetes Care Jun;26(6): UK prospective diabetes study 16. Overview of 6 years therapy of type II diabetes: a progressive disease. UK Prospective Diabetes Study Group. Diabetes v;44(11): MacLeod KM, Hepburn DA, Frier BM. Frequency and morbidity of severe hypoglycaemia in insulin-treated diabetic patients. Diabet Med Apr;10(3): Abraira C, Colwell JA, Nuttall FQ, Sawin CT, Nagel NJ, Comstock JP, et al. Veterans Affairs Cooperative Study on glycaemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Affairs Cooperative Study in Type II Diabetes. Diabetes Care Aug;18(8): Saudek CD, Duckworth WC, Giobbie-Hurder A, Henderson WG, Henry RR, Kelley DE, et al. Implantable insulin pump vs multiple-dose insulin for non-insulin-dependent diabetes mellitus: a randomized clinical trial. Department of Veterans Affairs Implantable Insulin Pump Study Group. JAMA Oct 23 30;276(16): United Kingdom Prospective Diabetes Study 24: a 6-year, randomized, controlled trial comparing sulfonylurea, insulin, and metformin therapy in patients with newly diagnosed type 2 diabetes that could not be controlled with diet therapy. United Kingdom Prospective Diabetes Study Group. Ann Intern Med Feb 1;128(3): Hepburn DA, MacLeod KM, Pell AC, Scougal IJ, Frier BM. Frequency and symptoms of hypoglycaemia experienced by patients with type 2 diabetes treated with insulin. Diabet Med Apr;10(3): Ziegher O, Kolopp M, Louis J, Musse JP, Patris A, Debry G, et al. Self-monitoring of blood glucose and insulin dose alteration in type 1 diabetes mellitus. Diabetes Res Clin Pract Jul;21(1): Ward WK, Haas LB, Beard JC. A randomized, controlled comparison of instruction by a diabetes educator versus self-instruction in self-monitoring of blood glucose. Diabetes Care May-Jun;8(3): American Diabetes Association. Executive summary: standards of medical care in diabetes Diabetes Care Jan;34 Suppl 1:S Ministry of Health Singapore. Clinical Practice Guidelines 2006 on Diabetes Mellitus [Internet]. SingPORE: Ministry of Health; 2006 Mar [cited Sep 2011]. 161 p. Available from: MungoBlobs/517/391/2006%20Diabetes_Mellitus.pdf. 95

8 Original Article PATIENT COMPONENT 1 a In the last 3 months, have you had any symptoms of sweatiness/ shivering/ giddiness/ hunger? SingHealth Polyclinics Hypoglycaemia Audit 2010 Questionnaire b If yes, how often do you get these symptoms? Once only 2 times c (i) (ii) d e f g h If yes, when do you usually get these symptoms: Time of day, please state time: In relation to meals What do you think was the cause of your symptoms? (Open-ended question, please state) What did you do when you had these symptoms? Did you check your hypo-count when you had these symptoms? If yes, what was your sugar level reading? Was there a recent adjustment to medication just before this attack? Were you unwell during the attack e.g. flu/ diarrhoea symptoms? Before breakfast Up to once a month Up to once a week Before lunch Before dinner Middle of night i Did you skip a meal just before that attack? j Where were you seen for that episode? GP Polyclinic A&E/Hospital Did nothing k Were there dose adjustments to your medication thereafter that episode? 2 Do you control your diet? t at all Sometimes Most of the time All the time 3 Do you exercise? t at all Sometimes Most of the time All the time 4 Do you take tablets for diabetes? t at all Sometimes Most of the time All the time 5 a Are you on Insulin Injections? Please state regime: b If yes, do you follow your insulin regime? t at all Sometimes Most of the time All the time 6 a Do you own a home blood sugar monitor? b 7 If yes, how often do you check your home blood sugar? Have you ever been admitted to hospital for low sugar/ hypoglycaemia before? NURSE COMPONENT 8 9 a b 10 a b What is the latest HbA1c reading for this patient? Does the patient know how to recognise hypoglycaemic symptoms? Does the patient understand the action plan for hypoglycaemia? In the last 3 months, does this patient have any documented low sugar readings <3.5mmol/L on home monitoring or in the case sheet? How frequent? If this patient has hypoglycaemia episodes, what is the most likely cause for this? (circle all appropriate) >than once a week Others, please state: Never Occasionally Monthly Weekly Daily Please state: % Acute Illness n-compliance to diet Increased medication or insulin regime Skipped meal/ Irregular meals Previously noncom-pliant, now compliant night snack Alcohol consumption Others, please state: Appendix I Insulin injection without food 96