Effectiveness and safety of insulin glargine in the therapy of complicated or secondary diabetes: clinical audit.

We wanted to assess the effectiveness and safety of glargine in the treatment of patients with type 2 diabetes mellitus in secondary failure and/or with severe comorbidities ("T2DM group"), and patients with secondary diabetes after corticosteroid and/or anticancer treatment ("secondary DM group"). We reviewed the records of patients on glargine from 1 August 2004 to 30 July 2005. The after-minus-before change in HbA1c was the main outcome measure. At baseline, the 18 "T2DM" patients had a mean (+/-SD) age of 66.7+/-9.5 years and a diabetes duration of 13.6+/-10.3 years; 52.9% were male. Their fasting plasma glucose (FPG) decreased from 228.6+/-76.6 to 134.6+/-37.5, two-hour post-prandial glycaemia (2hPPG) from 268.2+/-10.4 to 140.6+/-30.8 and HbA1c from 10.4+/-2.3 to 7.9+/-1.6%. Mean daily insulin dosage was 12.0+/-4.8 UI for glargine alone and 37.4+/-22.6 UI for basal-bolus scheme. The daily cost was Euro 0.75 (range Euro 0.31-1.15). The 24 "secondary DM" patients had a mean age of 67.0+/-11.0 years and a diabetes duration of 3.7+/-6.5 years; 54.2% were male and 91.7% had a metastatic cancer. Their FPG decreased from 222.3+/-108.6 to 121.5+/-28.7 mg/dl, 2hPPG from 259.4+/-108.6 to 133.0+/-35.0 mg/dl and HbA1c from 10.1+/-2.5 to 7.6+/-1.3%. Mean daily insulin dosage was 12.5+/-6.1 UI for glargine alone and 27.2+/-9.1 UI for basal-bolus scheme. Mean daily cost was Euro 0.70 (range Euro 0.31-1.38). One (4.2%) cancer patient withdrew from glargine because of nausea. Nine (37.5%) cancer patients had an increase in appetite after glargine therapy, including 3 end-of-life patients. No severe hypoglycaemia occurred. Insulin glargine was safe and effective in improving glycaemic control both in severe "T2DM" and in "secondary DM" patients.

How to start or change a daily insulin regimen without a specialist in diabetes. Effectiveness and RAND assessment of practical schemes for in-hospital or hospital-based home care services use.

When the diabetic patient is hospitalised or assisted by a hospital-based home care service, as a rule he/she is not cared for by a diabetologist all day long. The aim of the present work was to perform a RAND assessment of practical schemes to start or change a daily insulin regimen without a diabetologist. We created an expert panel of seven internists and two diabetologists. They judge the appropriateness of each practical scheme using the RAND method. We produced 21 clinical scenarios divided into two groups. The first group of 9 clinical scenarios-i.e., for diabetic patients who 'eat/not-always-eat' and are 'normal-weight/obese/underweight' or with 'renal failure' or 'defedated/end-of-life' or 'vomiting' or on 'parenteral nutrition'-useful for starting a daily insulin regimen without a diabetologist had a median RAND score of 8 (range 7-9). The second one-formed by 12 clinical scenarios useful to change the daily insulin dosage without a diabetologist based on low or high capillary glucose level monitoring-had a median RAND score of 9 (range 7-9). There was a high level of agreement between panellists in judging 'appropriate' the practical schemes to start or change a daily insulin regimen without a diabetologist.

Characteristics of Type 2 diabetic patients cared for by general practitioners either with medical nutrition therapy alone or with hypoglycaemic drugs.

The essential role of medical nutrition therapy (MNT) for people with diabetes is widely recognised, and its exclusive use is recommended in mild diabetes according to a stepwise therapeutic approach. We describe the characteristics of MNT-treated Type 2 diabetic patients (vs drugs) cared for by general practitioners (GPs) in order to check that appropriate differences did exist between the two groups, by auditing the data from our local shared-care program for diabetes. We had 16,000 diabetic patients (out of 630,000 inhabitants); 6,800 of them (42.5%) cared for by GPs. Thirty-one percent (2,079 out of 6,800 patients cared for by GPs) were treated with MNT and 69% with drugs. The MNT-treated patients (vs drugs) were younger (66.1 +/- 10.7 vs 67.7 +/- 11.0 yr, p<0.01), had shorter disease duration (8.2 +/- 6.6 vs 11.2 +/- 7.6 yr, p<0.01), lower HbA1c (7.0 +/- 1.1 vs 7.8 +/- 1.6%, p<0.01) and body mass index (BMI) (28.6 +/- 4.6 vs 29.0 +/- 4.9 kg/m2, p<0.01). They had less prevalence of high blood triglycerides (25.4% vs 29.0%, p<0.01). MNT-treated patients had less micro-albuminuria (5.3% vs 8.8%, p<0.01); less retinopathy both non-proliferant (6.5% vs 11.1%, p<0.01), and pre-proliferant (6.8% vs 12.7%, p<0.01), and proliferant (7.0% vs 12.9%, p<0.01); less peripheral neuropathy (3.9% vs 8.3%, p<0.01); and diabetic foot (1.0% vs 2.0%, p<0.01). They had less chronic heart failure (2.7% vs 4.6%, p<0.01), and claudicatio intermittens (3.3% vs 5.3%, p<0.01). In conclusion, the Type 2 diabetic patients cared for by GPs using MNT appropriately had a less severe form of diabetes.

Audit of a shared-care program for persons with diabetes: baseline and 3 annual follow-ups.

In Italy, data on shared-care programs for diabetes are lacking. We described the characteristics of type 2 diabetic population assisted in general practice and evaluated 3 years of follow-up outcomes and performance indicators in a shared-care program in Modena, Italy (1998-2001); only well-controlled diabetic patients were considered. Forty-nine percent of territorial GPs adhered to the project (257 out of 521) and 77% of them sent 6409 paired baseline and follow-up datasheets. Altogether, 97.8% patients had type 2 diabetes, mean age 68.6+/-11.7 years, disease duration 9.6+/-7.5 years, BMI 28.6+/-4.8 kg/m2, HbA(1c) 7.6%+/-1.6%, 16.1% of them were disabled. Among the non-disabled patients, 23.6% had optimal glycemic control (HbA(1c) < or =6.5%); at baseline the prevalence of micro- and macrovascular diabetic complications was: 8.2% microalbuminuria and 2.4% macroalbuminuria plus nephropathy, 11.0% nonproliferative and 3.0% preproliferative retinopathy, 7.0% neuropathy, 1.8% diabetic foot; 8.5% angina, 6.9% TIA or stroke, 6.3% infarction, 5.2% intermittent claudication, 4.1% heart failure. Among the disabled patients 27.9% had optimal glycemic control, but they had more diabetic complications. The performance indicators significantly improved over the 3-year study period: glycemic control indicators increased from 66%-75% to 83%-90% and micro- and macrovascular indicators from 59%-65% to 75%-81%. The outcome indicators also improved: mean HbA(1c) value changed from 7.6%+/-1.6% to 7.3%+/-1.3% and the percentage of people with HbA(1c)< or =6.5% significantly improved over time. Similar trends were observed in both disabled and non-disabled diabetic patients.

A diagnosis of left ventricular hypertrophy on ECG is associated with a high cardiovascular risk: findings from a 40- to 69-year-old cohort in general practice.

OBJECTIVE: Left ventricular hypertrophy (LVH) is an independent cardiovascular (CV) risk factor in both sexes. We studied if a diagnosis of LVH on electrocardiogram (ECG) was associated with a 'high CV risk condition' among 40- to 69-year-old individuals cared for by GPs. METHODS: We studied 4250 individuals, 5.4% of whom had LVH. Cross-sectional frequencies, and age- and gender-adjusted statistical differences have been calculated. RESULTS: All the study variables were significantly worse for 'LVH' than 'non-LVH' individuals (except smoking). The 'LVH' had both a mean '5-year CV risk' significantly greater than 'non-LVH' individuals (27.0% versus 8.6%), and a significantly higher prevalence of a '5-year CV risk >15%' (89% versus 15%). CONCLUSIONS: A diagnosis of LVH on ECG among the adult individuals of an opportunistic cohort from general practice was associated with a 6-fold greater prevalence of a 'high CV risk condition'.

GPs' satisfaction with the doctor-patient encounter: findings from a community-based survey.

OBJECTIVE: The aim of this study was to explore the characteristics of the doctor-patient relationship from the GP's point of view. METHODS: We performed a cross-sectional 1-day study in family practice. Thirty-three GPs volunteered to fill in a questionnaire at the end of each of 20 consecutive consultations on an index day. Six hundred and sixty-one patients (out of 665) participated in the study. Descriptive frequencies of GPs' judgements about personal experiences during the consultations, and predictors of GP's global satisfaction score on patient encounters were analysed. RESULTS: The mean age of the 33 GPs was 44.7 +/- 3.6 years. Professional skills (62% of the GPs had no doubts on diagnosis, therapy or prognosis) and the quality of the human/interpersonal interaction were major determinants of GPs' satisfaction in the patient-doctor relationship. Doctors felt professionally esteemed by 90% of their patients, and the median value of their global satisfaction score (matching the expectations from an 'ideal patient' to that experienced when meeting the real one) was very high (median 8, range 1-10). Nevertheless, GPs did not know if they were satisfied with the actual encounter with the patient in about one-third of the consultations. CONCLUSIONS: Professional skills and quality of the human/interpersonal interactions are major determinants of GPs' satisfaction in their professional activities.

Changes in long-term glycemic control and performance indicators in a cohort of type 2 diabetic patients cared for by general practitioners: findings from the "Modena Diabetes Project".

BACKGROUND AND AIM: General practitioners (GPs) are being increasingly asked to play a key role in the shared care of people with diabetes mellitus, but data concerning the effects of this in Italy are still scarce. We therefore evaluated the 4-year follow-up changes in outcomes and performance indicators in type 2 diabetic patients cared for by GPs in the framework of the "Modena Diabetes Project". METHODS AND RESULTS: Seventy-four percent of the local GPs participating in the project (387 out of 521) sent 5260 paired baseline and follow-up datasheets. The baseline characteristics of the type 2 diabetic patients (49.6% male) were a mean age of 67.3+/-11.2 years, a mean disease duration of 10.9+/-7.4 years, a mean BMI of 28.7+/-4.8 kg/m2, and a mean HbA1c level 7.56+/-1.52%. After four years follow-up, the individual before/after match-paired outcomes revealed an improvement in glycemic control: HbA1c levels significantly decreased to 7.39+/-1.31%, and the percentage of patients with HbA1c level of <6.5% significantly increased from 15.7% to 22.1%. There was also a significant decrease in body weight (from 78.3+/-14.8 to 77.6+/-14.6 kg) and BMI (from 28.8+/-4.8 to 28.5+/-4.9 kg/m2). The time trends of glycemic control significantly improved during the 4-year follow up, but those of the body weight and BMI values did not. Furthermore, the percentages of performance indicators matching the expected rate of recurrence per each year of follow-up significantly improved during the study period. CONCLUSIONS: Long-term glycemic control and the performance indicators relating to the type 2 diabetic patients participating in our shared care programme progressively improved.