Development and validation of the diabetes fear of injecting and self-testing questionnaire (D-FISQ): first findings

To quantify the degree of fear of self-injecting insulin and self-testing of blood glucose in adult insulin-treated diabetic patients, the Diabetes Fear of Injecting and Self-testing Questionnaire (D-FISQ) was developed. The D-FISQ is a 30-item self-report questionnaire consisting of two subscales that measure Fear of Self-Injecting (FSI) and Fear of Self-Testing (FST). To test validity and internal consistency, the D-FISQ was administered to a sample of 266 insulin-treated patients (Type 1 and Type 2); four diagnosed injection phobic insulin-requiring diabetic patients also completed the D-FISQ. The minimal score was obtained on the subscales by 62 % (FSI) and 57 % (FST) of the population. The D-FISQ demonstrated high internal consistency, with Cronbach’s αs of 0.94 (D-FISQ), 0.94 (FSI), and 0.90 (FST). Spearman rho between fear of self-injecting and fear of self-testing was 0.59 (p < 0.001), justifying two separate subscales. Construct validity was confirmed by a correlation of 0.44 with Spielbergers Trait Anxiety Inventory (Spearman rho, p < 0.001). FSI-scores from the injection phobic patients were all ≥95th percentile, while three scored ≥95 % on FST, indicating discriminative validity. Results confirm homogeneity and validity of the D-FISQ and suggest usefulness of this instrument in both clinical practice and research. © 1997 John Wiley & Sons, Ltd.     

Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a population-based study.

AIMS: To ascertain the frequency and identify predictors of self-reported hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes. METHODS: A random sample of 267 people with insulin-treated diabetes were recruited from a population-based diabetes register in Tayside, Scotland. Each subject prospectively recorded the number of mild and severe hypoglycaemic episodes experienced over a 1-month period. Ordinal logistic regression was performed to identify potential predictors of hypoglycaemia. RESULTS: Five hundred and seventy-two hypoglycaemic events were reported by 155 patients. The participants with Type 1 diabetes had a total of 336 hypoglycaemic events with a rate of 42.89 events per patient per year. Of these, nine were severe hypoglycaemic events, with a rate of 1.15 events per patient per year. Participants with insulin-treated Type 2 diabetes experienced a total of 236 hypoglycaemic events with a rate of 16.37 events per patient per year. Of these, five were severe hypoglycaemic events, which would be equivalent to 0.35 events per patient per year. Predictors of hypoglycaemia in Type 1 diabetes were a history of previous hypoglycaemia (P = 0.006) and co-prescribing of any oral drug (P = 0.048). In patients with insulin-treated Type 2 diabetes, a history of previous hypoglycaemia (P < 0.0001) and duration of insulin treatment (P = 0.014) were significant predictors. CONCLUSION: The incidence of self-reported severe hypoglycaemia in insulin-treated Type 2 diabetes is lower than in Type 1 diabetes but does occur more often than previously reported and with sufficient frequency to cause significant morbidity. Duration of insulin treatment is a key predictor of hypoglycaemia in insulin-treated Type 2 diabetes.     

Increased risk of diabetes among relatives of female insulin-treated patients diagnosed at 15-34 years of age.

AIMS: This study aimed to determine the risk of developing diabetes among relatives of patients diagnosed between 15 and 34 years of age who were treated with insulin. Our second aim was to determine whether there was a difference in risk of diabetes between relatives of male and female patients. METHODS: A questionnaire was sent to patients in the Diabetes Incidence Study in Sweden registry diagnosed between 1983 and 1993 to determine the presence of first-degree relatives with diabetes. RESULTS: In 3087 index patients treated with insulin, 17.8% (95% confidence interval 16.5, 19.2) had a first-degree relative (excluding offspring) treated with insulin, the frequency being higher in female (19.8%) than in male (16.5%, P = 0.018) patients. A total of 10.7% had a parent treated with insulin. The prevalence of insulin-treated diabetes was higher among parents of female (12.5%) than of male (9.5%), insulin-treated index patients (P = 0.0068). A similar difference was observed using life table analysis (P = 0.0025), which also showed that the risk by 63 years of age was 7.6% for parents of female and 4.9% for parents of male insulin-treated index patients. In insulin-treated index patients, 8.4% had a sibling with insulin-treated diabetes. CONCLUSIONS: We conclude that the risk for relatives of women with insulin-treated diabetes was higher than for relatives of insulin-treated male patients. We suggest that greater genetic susceptibility is required for females compared with males in the 15-34 age group in order to develop diabetes and hence females might carry more diabetes genes since more of their relatives also develop diabetes.     

Emotional distress is associated with poor self care in type 2 diabetes mellitus

Background: The aim of the present study was to evaluate possible clinical and psychosocial variables that influence diabetes self‐care management in patients with type 2 diabetes mellitus (T2DM). Methods: A total of 150 individuals with T2DM who had had diabetes for at least 6 months were recruited to this cross‐sectional study. Levels of self‐care and psychosocial status were determined using the Self‐Care Inventory (SCI) and Problem Areas in Diabetes (PAID) scale. The PAID scores were calculated using a five‐point Likert scale with options ranging from 0 (not a problem) to 4 (serious problem). Data were evaluated using non‐parametric and parametric tests as appropriate. Results: The mean age of the study participants was 69.97 ± 8.68 years. Cronbach’s α for SCI and PAID scores was 0.85 and 0.98, respectively. People with poor glycemic control had significantly higher mean (±SD) total PAID scores than individuals with good glycemic control (29.5 ± 30.9 vs 16.7 ± 26.9, respectively; P = 0.012). There was a significant relationship between PAID scores and glycemic control (r = 0.2; P = 0.012). Conclusions: The present study demonstrates that psychosocial factors directly influence glycemic control and diabetes self‐care habits. In addition, diabetes‐specific distress in study population was unrelated to the duration of diabetes, the age of the patients and anthropometric indices.     

Injection related anxiety in insulin-treated diabetes

The presence of injection related anxiety and phobia may influence compliance, glycaemic control and quality of life in patients with insulin-treated diabetes. Unselected consecutive, insulin-treated patients attending a diabetes clinic for follow-up, completed a standardised questionnaire providing an injection anxiety score (IAS) and general anxiety score (GAS). A total of 115 insulin-treated (80 Type 1 and 35 Type 2) diabetic patients completed the questionnaire. Injections had been avoided secondary to anxiety in 14% of cases and 42% expressed concern at having to inject more frequently. An IAS > or = 3 was seen in 28% of patients and of these, 66% injected insulin one to two times/day, 45% had avoided injections, and 70% would be bothered by more frequent injections. A significant correlation between IAS and GAS was seen (Kendall's tau-a 0.30, 95% CI 0.19-0.41, P < 0.001). GAS was significantly associated with both previous injection avoidance and expressed concern at increased injection frequency. No significant correlation was seen with HbA1c and injection or general anxiety scores. Symptoms relating to insulin injection anxiety and phobia have a high prevalence in an unselected group of diabetic patients requiring insulin injections and are associated with higher levels of general anxiety.     

Mortality of South Asian patients with insulin-treated diabetes mellitus in the United Kingdom: a cohort study.

AIMS: To investigate mortality in South Asian patients with insulin-treated diabetes and compare it with mortality in non South Asian patients and in the general population. METHODS: A prospective cohort study was conducted of 828 South Asian and 27 962 non South Asian patients in the UK with insulin-treated diabetes diagnosed at ages under 50 years. The patients were followed for up to 28 years. Ethnicity was determined by analysis of names. Standardized mortality ratios (SMRs) were calculated, comparing mortality in the cohort with expectations from the mortality experience of the general population. RESULTS: SMRs were significantly raised in both groups of patients, particularly the South Asians, and especially in women and subjects with diabetes onset at a young age. The SMRs for South Asian patients diagnosed under age 30 years were 3.9 (95% CI 2.0-6.9) in men and 10.1 (5.6-16.6) in women, and in the corresponding non South Asians were 2.7 (2.6-2.9) and 4.0 (3.6-4.3), respectively. The SMR in women was highly significantly greater in South Asians than non South Asians. The mortality in the young-onset patients was due to several causes, while that in the patients diagnosed at ages 30-49 was largely due to cardiovascular disease, which accounted for 70% of deaths in South Asian males and 73% in females. CONCLUSIONS: South Asian patients with insulin-treated diabetes suffer an exceptionally high mortality. Clarification of the full reasons for this mortality are needed, as are measures to reduce levels of known cardiovascular disease risk factors in these patients.     

Frequency and risk factors of severe hypoglycaemia in insulin-treated Type 2 diabetes: a cross-sectional survey.

AIMS: The reported risk of severe hypoglycaemia in insulin-treated Type 2 diabetes is highly variable and few studies have evaluated the influence of risk factors. We assessed the incidence and the influence of potential risk factors for severe hypoglycaemia in a questionnaire survey in subjects with insulin-treated Type 2 diabetes receiving currently recommended multifactorial intervention. METHODS: Consecutive patients with insulin-treated Type 2 diabetes (n = 401) completed a questionnaire about occurrence of hypoglycaemia in the past, hypoglycaemia awareness and socio-demographic factors. A zero-inflated negative binomial model was used to assess the influence of potential risk factors on the rate of severe hypoglycaemia. RESULTS: The overall incidence of severe hypoglycaemia in the preceding year was 0.44 episodes/person year. Sixty-six (16.5%) patients had experienced at least one event. The risk of any episode of severe hypoglycaemia positively correlated with impaired hypoglycaemia awareness, being married and long duration of diabetes. The risk of repeated episodes of severe hypoglycaemia positively correlated with the presence of peripheral neuropathy, while long duration of diabetes prior to insulin treatment and treatment with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor antagonists (ARBs) were associated with reduced risk. C-peptide concentration and HbA1c were not associated with the risk of severe hypoglycaemia. CONCLUSIONS: In this cohort of insulin-treated Type 2 diabetic patients, the incidence of severe hypoglycaemia is higher than reported in most studies, corresponding to about one-third of that in Type 1 diabetes. Impaired hypoglycaemia awareness is the most important risk factor for severe hypoglycaemia.     

Trends in the management of arterial hypertension in patients with type 1 and insulin-treated type 2 diabetes mellitus over a period of 10 years (1989/1990-1994/1995). Results of the JEVIN trial

SUMMARY: For populations of patients with insulin-treated diabetes mellitus, information about the quality of blood pressure control, an independent risk factor for cardiovascular mortality and morbidity, is widely lacking. Hence, it was the goal of the trial to evaluate the prevalence of arterial hypertension, the quality of blood pressure control and changes in treatment modalities over a period of 10 years. PATIENTS AND METHODS: In 1989/1990, Jena's St. Vincent (JEVIN) Trial started as a prospective, population-based survey with 10-year follow-up of all patients with type 1 and insulin-treated type 2 diabetes mellitus aged 16 to 60 years and living in the city of Jena, Thuringia, Germany. RESULTS: In 1999/2000, 46 (40.4%) of 114 patients with type 1 and 104 (70.7%) of 147 patients with insulin-treated type 2 diabetes were on blood pressure-lowering drugs. Hypertension prevalence in the total population was 57.5%. It was higher in patients with insulin-treated type 2 than in type 1 diabetes (47.4% vs. 78.9%, P<.001). In 1999/2000, the number of patients with type 1, but also type 2, diabetes on blood pressure-lowering agents was higher than in 1994/1995 and 1989/1990. In the whole group, the mean blood pressure improved from 1989/1990 up to 1994/1995 and has remained constant up to the follow-up examination in 1999/2000. In 1999/2000, of those with arterial hypertension, blood pressure was higher than the 140/90-mm Hg target in 17.5% (20/114) of the patients with type 1 and in 42.2% (62/147) of the patients with insulin-treated type 2 diabetes. CONCLUSIONS: The JEVIN trial provides a useful population-based summary of the quality of blood pressure and metabolic control of patients with insulin-treated diabetes. Although the trial demonstrates an impressive improvement in the quality of blood pressure and metabolic control over the last decade, it also shows various problems: In many patients, both with type 1 and type 2 diabetes mellitus, a good blood pressure control (below 140/90 mm Hg) has not been achieved. Moreover, drug therapy, in particular concerning patients with overt nephropathy, is often inappropriate.     

Association of diabetes-related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes.

AIMS: To characterize the determinants of diabetes-related emotional distress by treatment modality (diet only, oral medication only, or insulin). METHODS: A total of 815 primary care patients with Type 2 diabetes completed the Problem Areas in Diabetes (PAID) Scale and other questions. We linked survey data to a diabetes clinical research database and used linear regression models to assess the associations of treatment with PAID score. RESULTS: PAID scores were significantly higher among insulin-treated (24.6) compared with oral-treated (17.8, P < 0.001) or diet-treated patients (14.7, P < 0.001), but not different between oral- vs. diet-treated patients (P = 0.2). Group scores remained similar, but the statistical significance of their differences was reduced and ultimately eliminated after sequential adjustment for diabetes severity, HbA(1c), body mass index, regimen adherence, and self-blood-glucose monitoring. Insulin-treated patients reported significantly higher distress than oral- or diet-treated patients on 16 of 20 PAID items. 'Worrying about the future' and 'guilt/anxiety when ... off track with diabetes' were the top two serious problems (PAID >or= 5) in all treatment groups. Not accepting diabetes diagnosis was a top concern for oral- and diet-treated patients, and unclear management goals distressed diet-treated patients. CONCLUSIONS: Primary care patients treated with insulin reported higher diabetes-related emotional distress compared with oral- or diet-treated patients. Greater distress was largely explained by greater disease severity and self-care burdens. To improve diabetes-specific quality of life, clinicians should address patients' sense of worry and guilt, uncertain acceptance of diabetes diagnosis, and unclear treatment goals.     

Improving self-management in insulin-treated adults participating in diabetes education. The role of overprotection by the partner.

AIMS: To examine the role of overprotection by the partner--i.e. excessive protection, unnecessary help, excessive praise for accomplishments, or attempts to restrict activities as a consequence of underestimating the patient's capabilities--in changes in patient self-management in the context of diabetes education. METHODS: Sixty-seven insulin-treated patients with a partner completed questionnaires on admission to a Multidisciplinary Intensive Education Programme (MIEP) and 3 months after completing the core module of MIEP. Factors assessed were overprotection by their partner and three aspects of diabetes self-management, namely internal locus of control, diabetes-related distress and HbA1c. Regression analyses were used to test the independent associations of patient sex, baseline overprotection and the interaction between sex and overprotection with diabetes self-management at the follow-up stage, controlling for the baseline value of the dependent variable. RESULTS: The increase in internal locus of control and decrease in HbA1c were both significantly less for female patients who perceived their partner to be rather overprotective than for female patients who did not perceive their partner to be overprotective. The more patients, both male and female, perceived their partner to be overprotective, the less their diabetes-related distress decreased. CONCLUSIONS: Overprotection by the partner showed a negative association with improvement in diabetes self-management, especially for female patients. Thus, an intervention programme with the aim of reducing overprotection by the partner, or the perception of this, may enhance self-management in patients participating in diabetes education.     

Management of diabetes in French prisons: a cross-sectional study.

AIMS: To assess by a survey the management of prisoners with diabetes treated with insulin in French prisons. METHODS: A questionnaire was sent to the head of healthcare services for prisoners of every French prison. Information was obtained on prevalence of insulin-treated diabetes prisoners and diabetes care in prison. The number of episides of ketoacidosis and hypoglycaemia needing hospital admissions were evaluated during the past year. RESULTS: Among the 163 questionnaires sent, 115 were returned, giving an overall response rate of 69%. At the time of the study the prison population was 38 175 people. One hundred and sixty-nine prisoners were treated by insulin (0.4%). Self-monitoring of blood glucose was available only for 94 (55.6%) insulin-treated prisoners. A total of 130 (76.9%) prisoners performed two insulin injections daily or less, 105 (62.1%) prisoners were not allowed to keep their insulin delivery systems with them. Of the prisoners who treated themselves, 14 (12.1%) used syringes and 42 (36.5%) used pen devices. Ninety-two (55.1%) prisoners had had access to a diabetes specialist during the previous year. Diabetic diets were available in only 65 (60.7%) prisons. From June 1998 to June 1999, there were 20 hospital admissions for a diabetic ketoacidosis and 14 for hypoglycaemia. CONCLUSIONS: This study shows that prison decreases the autonomy of diabetic prisoners who often cannot self-inject or test their blood. Access to visiting consultant diabetologists and specialist nurses to educate both prisoners with diabetes and prison staff could improve diabetic care.     

An evidence-based review and guidelines for patient self-testing and management of oral anticoagulation

There is a limited evidence base for self-testing and -management for oral anticoagulation management. Available data suggest that these are credible models for a significant minority of patients if underpinned by structured training and follow-up. The guidelines presented are necessarily consensual and outline procedures for patient selection, training, product procurement, product maintenance, quality assurance procedures, dosage adjustment and clinical supervision. The cost-effectiveness of these models remains to be elucidated within the UK. Further data on both health economic and clinical outcomes are required from UK based studies before widespread implementation of self-testing and management can be recommended on a wider scale.     

Diabetes knowledge and its determinants in a Mexican population.

PURPOSE: The purpose of this study was to measure the level of diabetes knowledge in a representative group of Mexican individuals with diabetes and to identify the factors that influence it. METHODS: A validated questionnaire was administered to 570 outpatients; 11.2% had Type 1 diabetes, 36.4% had Type 2 diabetes treated with insulin, and 52.2% had Type 2 diabetes treated with oral agents. Samples for HbA1c determination also were obtained. RESULTS: The percentage of correct answers in each section of the questionnaire was low. Type 1 patients had the highest scores, followed by the insulin-treated Type 2 patients; those with chronic complications also had high scores. Educational background, attendance at diabetes courses, age, and HbA1c concentration were the main predictors of knowledge. Attendance at courses was influenced by the severity of the disease. CONCLUSIONS: The amount of patient knowledge about diabetes-related issues was low in this representative Mexican population. The educational efforts were focused on those with the worst metabolic control and/or with diabetes complications.     

Patient–provider perceptions of diabetes and its impact on self‐management: a comparison of African‐American and White patients

Aims To compare patient–provider differences in diabetes‐related perceptions between African‐American and White patients and to examine its association with self‐care behaviours. Methods One hundred and thirty patient–provider pairs were recruited from the greater Detroit area. Patients and providers completed a survey assessing perceptions about diabetes‐related concepts and demographic background. The Diabetes Semantic Differential Scale was used to measure diabetes‐related perceptions. Patients also reported the frequency of performing self‐care behaviours, including following a healthy eating plan, engaging in physical activity, blood glucose monitoring, and taking medication and/or insulin. Results There were a greater number of patient–provider differences in diabetes‐related perceptions for the African‐American patients (nine of 18 concepts) compared with the White patients (four of 18 concepts). Stepwise regression analyses found patients’ semantic differential scores to be significantly associated with five self‐care behaviours for African‐American patients and two self‐care behaviours for White patients. Providers’ semantic differential scores emerged as predictors of self‐care behaviours for African‐American patients, but not for White patients. Conclusions Our findings suggest that compared with White patients, African‐Americans differ in a greater number of diabetes‐related perceptions than their providers. Patients’ and providers’ perceptions of diabetes care concepts have a significant impact on a greater number of self‐care behaviours for African‐American patients than White patients.     

Birthweight and other pregnancy outcomes in a cohort of women with pre-gestational insulin-treated diabetes mellitus, Scotland, 1979-95.

AIMS: To assess pregnancy outcomes, in particular birthweight, in a large population-based cohort of women in Scotland with pre-gestational insulin-treated diabetes mellitus. METHODS: Data about diabetes from the Diabetes UK cohort were linked to data on births from the Scottish Hospital In-Patient Record System. This identified 1112 eligible singleton deliveries during 1979-95 to 706 insulin-treated women. RESULTS: One thousand and eighty-four (97.5%) deliveries resulted in a live-born infant and 28 (2.5%) in a stillbirth. There were 13 (1.2%) neonatal deaths. The mean birthweight of the live-born infants was 3421 g, 1.06 standard deviations greater than that of infants in the Scottish general population after correcting for sex and gestational age. Forty-three per cent of live-born babies in the study were large (> Scottish 90th percentile) and 4% small (< 10th percentile) for their sex and gestational age. Macrosomia, defined as birthweight > or = 4000 g, occurred in 23% live-born babies and its prevalence was significantly inversely related to duration of maternal diabetes. However, the mean birthweight of infants born to mothers with diabetes for 20 or more years was still 0.90 standard deviations greater than in the general population. Prevalence of macrosomia increased with increasing number of previous pregnancies, but was not associated with maternal height or smoking habits. Stillbirth and neonatal death rates were, respectively, 4.7 (95% confidence interval = 3.3, 6.8) and 2.4 (1.4, 4.1), times higher than those in the general population. CONCLUSIONS: The frequency of adverse pregnancy outcomes in women with pre-existing insulin-treated diabetes was much higher than in the Scottish general population, and changed little during the study period. A detailed quantification of the independent effect of duration of mother's diabetes on birthweight revealed a continuous inverse correlation between these two variables.     

Incidence of Insulin-dependent Diabetes Mellitus in Age Groups Over 30 years in Denmark

The incidence of IDDM in the age group over 30 years was estimated in a historical prospective study, using clinical and biochemical measurements at onset as criteria for classification. The study population, nearly one million, represents 20% of the Danish population. The degree of ascertainment was >99%. One thousand two hundred and forty patients were treated with insulin during the study period (1973–77). Based on the clinical and biochemical variables, the patients were classified into three groups: insulin-dependent diabetes mellitus (IDDM) accounted for 16.2%, insulin-treated diabetes mellitus for 54.1% and short-term treated diabetes mellitus for 29.6% of the total insulin-treated group. The incidence of IDDM in the age group over 30 years at onset was 8.2 100 000^?1 year^?1. The cumulative incidence rate (0–90 years) was 1.5–1.6 per cent. The present study indicates that IDDM may develop at any age. Thus the life-time risk of developing IDDM is higher than hitherto expected.     

Use of a Combined Blood-Glucose- and ?-Ketone-Measuring Device Improves Glycemic Control in Insulin-Treated Patients With Diabetes: The Gold Plus Study

Background:Using self-measurements of blood glucose (SMBG) is daily routine for patients with insulin-treated diabetes, however measuring ß-ketones in blood is not widespread. How the use of a combined device, which can measure both, is accepted in daily routine by patients and will lead to better glycemic control is not well studied.Methods:This multicenter, prospective, noninterventional study assessed the impact of routine use of the GlucoMen® LX Plus on patient acceptance, usage and glycemic control among insulin-treated patients with diabetes mellitus type 1 and type 2. A1c and self-reported frequency of SMBG were evaluated at baseline and also postprandial SMBG, ß-ketone measurements, and use of reminders after 3 and 6 months of use. A total of 631 patients, 254 type 1/350 type 2 (27 no type specified), with mean (SD) baseline A1c 8.5% (1.5), age 54.6 (15.6) years, and 47.3% female were studied.Results:Frequent use of SMBG at baseline led to a higher decrease in A1c at 6 month (V3): –0.3% if SMBG measured up to 1/day versus −0.9% in 4-6/day. Increase of SMBG frequency during the study showed also a negative correlation to A1c, 9.2% at V1 versus 7.6% at V3. Postprandial SMBG was done by 77.7% and ß-ketone measurements by 45.5% of all patients; the reminders were used by 33.4% and led to an increased frequency of SMBG at 6 months.Conclusions:A combined device for SMBG and ß-ketone measurements is well accepted by patients with insulin-treated diabetes and can lead through the avoidance or detection of ketoacidosis/increased frequency of SMBG and increased awareness of the patients to an improved glycemic outcome.     

Impaired awareness of hypoglycaemia: a review

Impaired awareness of hypoglycaemia (IAH) is an acquired complication of insulin therapy, which affects people with type 1 and insulin-treated type 2 diabetes mellitus, whereby the ability to perceive the onset of hypoglycaemia becomes diminished or absent. Deficiencies of the counter-regulatory hormonal responses to hypoglycaemia usually co-exist. The development of IAH and counter-regulatory failure greatly increases the risk of severe hypoglycaemia. Scoring systems have been developed that can be used in the clinical setting and assist with identification of this group of individuals at risk of severe hypoglycaemia. The mainstay of treatment of IAH is the scrupulous avoidance of hypoglycaemia.     

Long-term effects of a structured intensive diabetes education programme (SIDEP) in patients with Type 2 diabetes mellitus--a 4-year follow-up study.

AIMS: Patient education is a very important part of diabetes care. However, until now, little data has been presented about the long-term effectiveness of structured intensive diabetes education programmes (SIDEP) for people with Type 2 diabetes mellitus. METHODS: People with Type 2 diabetes (n = 547) hospitalized from December 1999 to December 2000 were randomly assigned to two groups. Two hundred and nineteen patients undertook an inpatient SIDEP and the remaining patients received conventional glycaemic control without intensive education. After discharge, all patients were monitored regularly. Laboratory data were obtained, and adherence to self-care behaviour was determined on a five-point scale by questionnaires completed annually. RESULTS: Of the patients who completed the SIDEP, 160 (73.1%) were followed up for more than 4 years. The mean HbA(1c) (7.9 +/- 1.2 vs. 8.7 +/- 1.6%; P < 0.05) and the frequency of hospitalization related to diabetes per patient per year (0.3 +/- 0.6 vs. 0.8 +/- 0.9; P < 0.05) was significantly lower in the SIDEP group than in the control group. The SIDEP group adhered more closely to self-care behaviour than the control group over 4 years (P < 0.05). People with Type 2 diabetes mellitus of longer duration and those treated with insulin had poorer HbA(1c) at follow-up. CONCLUSIONS: A well-designed, intensive patient education programme is necessary for people with diabetes. However, regular and sustained reinforcement with encouragement is also required to maintain optimal glycaemic control, especially in insulin-treated patients.