Evaluation of a 5-day education programme in type 1 diabetes: achieving individual targets with a patient-centred approach.

AIMS: To evaluate if a single inpatient education training programme can achieve individualized therapeutic targets. METHODS: Patients with Type 1 diabetes participating in a flexible intensive therapy programme were consecutively included in a prospective monocentric study. They all participated in the same education programme which had a patient-centred approach. Before the intervention, patients were divided into three groups according to their main therapeutic target: Group 1, to decrease HbA1c concentration in patients with baseline HbA1c ≥ 58 mmol/mol (7.5%); Group 2, to improve quality of life and satisfaction with treatment in patients with baseline HbA1c < 58 mmol/mol (7.5%); and Group 3, to decrease the frequency of hypoglycaemic episodes in patients with severe or frequent hypoglycaemic episodes. Therapeutic targets were evaluated at 12 months. Quality of life and treatment satisfaction were evaluated with validated questionnaires completed at baseline and 6 months. RESULTS: In Group 1 (n = 74), the mean ± sd HbA1c concentration decreased from 75 ± 15 mmol/mol (9.0 ±1.4%) to 68 ±15 mmol/mol (8.4 ± 1.4%; P < 0.001), with 53% of patients experiencing a decrease in HbA1c concentration of at least 6 mmol/mol (0.5%), without weight gain or more frequent hypoglycaemia. In Group 2 (n = 12), patient satisfaction with treatment improved significantly (P < 0.0001). In Group 3 (n = 35), minor hypoglycaemia significantly decreased from a mean ± sd of 6.6 ± 4.7 to 3.2 ± 3.0 hypoglycaemic episodes/week (P < 0.001) and the incidence of severe hypoglycaemia dropped significantly from a mean ± sd of 2.31 ± 3.07 to 0.86 ± 2.46 episodes/patient/year (P < 0.001). CONCLUSIONS: Many patients with different needs, who attended the same flexible intensive therapy education programme, which had a patient-centred approach, were able to achieve their individual therapeutic targets.

Insulin therapy for type 2 diabetes: premixed or basal-prandial?

It is logical to begin type 2 insulin therapy with an injection of an intermediate-acting or a long-acting insulin at bedtime, but one should treat to target, i.e. aim at fasting glycaemias lower than 1.20 g/l to obtain an HbA(1c) close to 7%. Nevertheless, basal insulin therapy does not prevent progression to insulin-secretory deficiency. If necessary, recourse should be made to multiple-injection protocols, taking into account postprandial hyperglycaemia. For every level of HbA(1c), the suppression of postprandial hyperglycaemia, 1 point of HbA(1c) can be gained in theory, whereas reducing the fasting glycaemia to values of less than 1.10 g/l reduces HbA(1c) to close to 7%, whatever the initial level of HbA(1c). However, when a diabetic is clearly not controlled, the preprandial acting use of rapid analogues allows the fasting glycaemia to be improved significantly. Inversely, an early treatment with basal insulin, by correcting glucotoxicity, can also decrease postprandial hyperglycaemia. Many industry-sponsored studies comparing insulin therapy regimens show annoying biased interpretations of results. It does not seem pertinent to compare a single injection with two or even three injections, nor to compare an efficient titration with an inefficient titration or to eliminate oral drugs, in particular sulphonylureas combined with a basal insulin. If premix insulins can give satisfactory results in patients who maintain a sufficient residual insulin-secretion, we think it would be preferable to adopt the basal-prandial regimen and a step-by-step escalating therapy. The first stage consists in combining oral therapy with an injection of NPH insulin or a long-acting analogue at bedtime, aiming at a fasting glycaemia of less than 1.20 g/l. In the next stages, a single injection of rapid-acting insulin analogue is added each time. The main advantage of this regimen is to fix a target adapted to each injection and, as a result, to facilitate forced titration of the doses.

Should diabetic patients be asked to test their blood glucose 90 to 120 minutes after the beginning of their meals?

There are three distinct objectives in reducing the post-prandial blood glucose peaks: 1st to reduce the risk of foetal macrosomia in pregnancy, 2nd to reduce cardiovascular morbi-mortality, 3rd to lower the HbA1c. With 6-7 glycaemic controls per day and fractionning their meals, motivated women with gestational diabetes reach this goal. But there is no data today directly proving that post-prandial glycaemia is specifically related to the development of micro and macrovascular complications. So to reduce the cardiovascular risk, there are more arguments in favour of lowering HbA1c or prescribing statins than in prescribing a hypoglycaemic drug acting selectively on post-prandial glycaemia. Lastly, to reduce HbA1c near to the goal of 7%, the most important is to reduce the preprandial glycaemia below 1.20 g/l. The patients must be required to monitor their post-prandial glycaemia 2 hours after the beginning of the meal only when the aim is to lower the HbA1c below 7% or 6.5%, for example during pregnancy, or in case of discrepancy between glycaemia at 8 a.m. and 7 p.m. (below 1.20 g/)l and HbA1c (above 7%). In other cases, in type 2 diabetes, two glycaemias per day, fasting and vesperal, seems sufficient.

Identification of factors associated with impaired hypoglycaemia awareness in patients with type 1 and type 2 diabetes mellitus.

OBJECTIVES: To assess clinical factors associated with impaired hypoglycaemia awareness (HA). METHODS: Survey of 241 type 1 and type 2 diabetic patients hospitalised in a diabetes department for a diabetes education program. Demographic, diabetes and psychiatric characteristics and subjective hypoglycaemic symptoms were recorded by a self-report questionnaire. RESULTS: Age and body mass index (BMI) was greater and glycated haemoglobin was lower in diabetic patients reporting impaired HA, however, these latter differences became not significant when age was included as a covariate. There were significantly more current smokers among those with impaired HA and controlling for age accentuated this difference. Current treatment by insulin was not associated with impaired HA. Backward stepwise logistic regression showed that type 2 diabetic patients were twice as likely to have impaired HA than type 1 diabetic patients (OR = 2.195, 95% CI: 1.017-4.734, P = 0.04). Moreover, higher age, current smoking and type 2 diabetes interacted significantly in increasing the likelihood of impaired HA. Among those with impaired HA more patients experienced drowsiness and nervousness and less patients reported tremor during the hypoglycaemic episodes. No other symptoms were associated with impaired HA. CONCLUSION: Type 2 diabetic patients, whether on insulin or not, and especially if they are of advanced age and if they smoke, are at increased risk of impaired HA.

Limitations of the so-called "intensified" insulin therapy in type 1 diabetes mellitus.

Intensive insulin treatment is defined by basal-prandial insulin therapy which tries to reproduce physiological insulin secretion. This requires 3 to 5 injections and self-monitoring of blood glucose 4 to 5 times a day. Patients who accept their disease and the demanding treatment regimen most often achieve HbA1(c) < 7.5%. Severe complications of diabetes can be avoided without increasing the risk of severe hypoglycemia. However, 50% of type 1 diabetic patients do not reach this objective. The reasons are: the disease itself, the diabetic patient, or the physician. Brittle diabetes with severe, repeated episodes of hypoglycemia and inversely persistent postprandial hyperglycemia prevents patients from reaching the ideal glycemic target. More often, the main obstacle is related to psychological problems: difficulties in self-regulation, denial of the disease, or phobia of hypoglycemia with avoidance behavior. Frequently, young women present eating disorders which can explain the poor diabetes control. The physician himself may be implicated in these poor glycemic results by not prescribing the right tools to obtain optimal glycemic control (staying with just two daily injections with premixed insulin) or by assigning glycemic targets inaccessible for the patient, or when an empathic relationship cannot be established between the patient and the physician. Patient empowerment is the key to the success of functional insulin treatment.

[Self-monitoring blood glucose in type 2 diabetes: for whom? And why? Which proofs?]. / Autosurveillance glycémique au cours du diabète de type 2: pour qui et pour quoi faire? Quelles preuves?

Though the importance of self-monitoring blood glucose (SMBG) for type 1 diabetes is widely acknowledged, it is still questioned in type 2 diabetes, at last when it is not treated with insulin. Indeed, SMBG appears to be efficient only when it is integrated into a strategy of self-treatment, which leads the patient to adapt his treatment to his blood sugar tests. Passive self-control is useless, and can even favour increasing anxiety or frustration. Numerous problems are still to be solved, be it concerning the adaptation of the treatment - the number of tests per day or per week, the kind of therapeutic adaptation, etc - or concerning the therapeutic education, which should correspond to the patient's personality and to his strategy of treatment. Evaluating the locus of control of the patients could help to single out those who could benefit from SMBG. The development of SMBG, whose cost is financed by social Security in France, is a good mirror of the patients' increasing wish to be informed about their treatment and to take an active part in it. Yet prospective randomised studies are still needed to confirm the efficiency of SMBG in type 2 diabetes.

Comparison of two diagnostic tests for gestational diabetes in predicting macrosomia.

OBJECTIVES: To validate a diagnostic test for gestational diabetes which predicts the risk of macrosomia. METHODS: A prospective study was carried out among 354 women at risk for gestational diabetes to compare two glucose tests diagnosing pregnancies at risk of macrosomia. The "practical" test consisted in glucose measurement in the fasting state and two hours after an usual breakfast and the "reference" test was the test proposed in France (O'Sullivan test with or without a 100 g oral glucose tolerance test). Both tests were made between the 24(th) and 28(th) week of gestation. Women at high risk for macrosomia were treated. The first assessment criterion was macrosomia (babies large for gestational age). Because of the presence of women treated for gestational diabetes in our sample, the sensitivity and specificity of the tests in diagnosing pregnancies at risk of macrosomia were calculated using either the incidence of macrosomia observed in our population, or the incidence of macrosomia observed theoretically in the absence of treatment (22% in literature). RESULTS: Macrosomia was diagnosed in 49 neonates (14%). The "practical" test was significantly more sensitive than the reference test (respectively 46.9% versus 16.3%, p=0.0001 in the first case, and 54.3% versus 20.1%, p=0.0001 in the second case). The "reference" test was significantly more specific than the "practical" test (respectively 80% versus 68.2%, p=0.0001 in the first case, and 80.6% versus 70%, p=0.0001 in the second case). CONCLUSION: Our study shows that the simplified "practical" test is more sensitive than the "reference" test currently used in France in screening women at risk of macrosomia.

Functional intensified insulin therapy with short-acting insulin analog: effects on HbA1c and frequency of severe hypoglycemia. An observational cohort study.

OBJECTIVES: To assess the effect of a particular insulin regimen called "functional insulin therapy" using a short-acting insulin analog on the risk of severe hypoglycemia and the HbA(1c) level among patients already under intensive insulin therapy. DESIGN: A cohort of 110 patients with type 1 diabetes receiving intensive insulin therapy with regular insulin for several years was followed during one year after initiation of functional insulin therapy (FIT) with a short-acting insulin analog. The glycemic control was assessed by the mean value of the last three HbA(1c) assays before the initiation of FIT and then by the mean of the following three. The number of severe hypoglycemic episodes/patient/year during the year preceding and the year following the initiation of FIT was recorded. RESULTS: The mean HbA(1c) level decreased on average by 0.7 percent during the 12-month study (p=0.0001) and the number of episodes of severe hypoglycemia fell to 75% of its previous level (p<0.05). CONCLUSION: Substitution of intensive insulin therapy using regular insulin for functional insulin therapy using short-acting insulin analog may improve glycemic control and reduce the risk of severe hypoglycemia.

How type 1 diabetic patients with good or poor glycemic control cope with diabetes-related stress.

OBJECTIVE: To determine the link between glycemic control and the strategies adopted by patients in coping with diabetes-related stress. MATERIAL AND METHODS: In a cross-sectional study of 122 type 1 diabetic patients, glycemic control was evaluated on the basis of the last mean annual HbA(1c) level, and a comparison was made of two groups of patients, i.e., those with "good control" (HbA(1c)<7.5%) and "poor control" (HbA(1c) > 8.5%). Sociodemographic were collected for all patients by the referring physician. The nature of the diabetes-related stress and the coping strategies adopted by patients were determined by analyzing validated self-assessment questionnaires. RESULTS: Comparison showed that there was no significant difference between the two groups in terms of the patients' age, level of education, age at onset, duration of the diabetes, or the nature of diabetes-related stress factors. In contrast, the difference between the groups was significant in that patients in the "well controlled" group carried out more home blood glucose tests (p<0.02), had fewer complications (p<0.003), and made greater use of so-called "task oriented" strategies (p=0.023), regardless of the existence of any complications. CONCLUSIONS: Even though the nature of the diabetes-related stress appears to be the same for the two groups, type 1 diabetic patients with good glycemic control manage their condition differently (more frequent home blood glucose tests) and use coping strategies that place greater emphasis on problem solving.

Propranolol in hypoglycaemia unawareness.

The effect of propranolol on the occurrence of hypoglycaemic symptoms was assessed in insulin-dependent diabetic patients with hypoglycaemia unawareness. A double-blind, randomised parallel group study (2:1 fashion) was conducted over 4-week period. The propranolol group (n = 9) received 20 mg (week 1 and 2) and 30 mg (week 3 and 4) twice daily, and the other group (n = 5) a matched placebo for 4 weeks. Patients included had experienced at least two severe hypoglycaemic episodes (coma or seizures) during the previous year, which were characterised by a lack of adrenergic symptoms and required the assistance of another person. The mean number of hypoglycaemias during the study period was similar in both groups (placebo: 13 +/- 2 propranolol: 11 +/- 1), whereas the number of totally asymptomatic hypoglycaemias (< 0.6 g/l) was lower on propranolol than on placebo (3 +/- 1 vs 8 +/- 3, NS) and the number of symptomatic hypoglycaemias was higher (7.2 +/- 2 vs 4.6 +/- 1, NS). Subjective evaluation of treatment by the investigators showed 0/5 successes in the placebo group and 5/9 in the propranolol group (chi2 = 4.32, p = 0.038). The main advantage of propranolol over placebo was an increased incidence of sweating. The ratio [number of hypoglycaemias with sweating/total number of hypoglycaemias] being higher with propranolol (0.28 +/- 0.08 vs 0.06 +/- 0.02, p = 0.06). This pilot study suggests that beta-blockers may be useful in restoring adrenergic symptoms during hypoglycaemia in insulin-dependent diabetic patients without warning symptoms of hypoglycaemia. This beneficial effect seems to be predominantly related to an increase in hypoglycaemia-induced sweating. A larger study is needed to confirm or invalidate these preliminary results.

Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycemic control in type I diabetic adults.

OBJECTIVE: To investigate the presence of psychiatric disorders and symptoms in type I diabetic patients and to identify those that may influence metabolic control as assessed by GHb levels. RESEARCH DESIGN AND METHODS: This was a cross-sectional study. One hundred and two consecutive patients with type I diabetes who were regular outpatient visitors of a diabetology department were evaluated. The psychiatric assessments included self-rating questionnaires (General Health Questionnaire and Fear Questionnaire) and observer-rating questionnaires (Montgomery-Asberg Depression Rating Scale [MADRS] and Mini International Interview). Diabetic characteristics were assessed by a structured interview. The observer was blind to the diabetic characteristics of the patients. RESULTS: Type I diabetic patients with GHb levels > or = 8% had higher psychological distress, scored significantly higher for symptoms of agoraphobia and for fear of blood and injury, had substantially higher levels of anxiety-depression, and performed significantly fewer blood glucose measurements per day. They did not differ in MADRS score from patients with GHb levels < 8%. Multivariate analysis showed that GHb was positively associated with the total score of phobic symptoms and the level of anxiety-depression and inversely associated with the number of daily blood glucose measurements. These factors explained 41% of the variance of GHb. The inverse relationship between GHb and the number of blood glucose measurements per day was mainly influenced by the fear of blood and injury. Patients with high scores for the fear of blood and injury performed fewer blood glucose measurements and had poorer glycemic control; conversely, subjects without fear of blood and injury performed more daily blood glucose measurements and had better glycemic control. CONCLUSIONS: Phobic symptoms are frequent in patients with type I diabetes. The intensity of phobic symptoms and anxiety-depression negatively influences metabolic control. Increased fear of blood and injury may lead some patients to perform few home blood glucose measurements and may result in poorer glycemic control. This suggests that, by decreasing the fear of blood, injury, and injection, metabolic control may be improved.

Treatment of osteomyelitis in the diabetic foot. Contribution of conservative surgery.

OBJECTIVE: To compare the duration of healing of foot ulcers with osteomyelitis in diabetic patients treated by medical treatment versus medical treatment associated with conservative orthopedic surgery. RESEARCH DESIGN AND METHODS: We entered into the study 67 diabetic patients who had a foot ulcer with osteomyelitis without ischemia requiring a peripheral arterial reconstruction. Thirty-two diabetic patients were included in a first historic group from 1986 to 1993, treated by antibiotic therapy, offloading, and wound care. Thirty-two patients were included from September 1993 to March 1995, treated by the same medical treatment and conservative orthopedic surgery. RESULTS: The healing rate was 57% in the group treated by the medical treatment alone versus 78% in the surgical group (P < 0.008). The duration of healing was 462 +/- 98 days versus 181 +/- 30 days (P < 0.008). CONCLUSIONS: Conservative surgery contributes to an increase in the healing rate of foot ulcers with osteomyelitis compared with a medical treatment alone.

Association between intra-abdominal fat and hypertension in android obese diabetics.

We have examined the relationship between visceral fat measured by MRI on a transverse cut through L3, insulin sensitivity assessed by the somatostatin-insulin-glucose test, and arterial blood pressure in 18 obese (11 women and 7 men), non insulin-dependent diabetic patients with android body fat distribution. Extent of visceral fat and insulin sensitivity were not different between women and men. Insulin sensitivity correlated significantly with visceral fat (r = -0.54, p < 0.05) but not with body mass index, L3 subcutaneous fat, or with waist to hip circumference ratio. Moreover, insulin sensitivity was lower in hypertensive compared to normotensive diabetic patients (Steady State Plasma Glucose = 18.8 +/- 3 mmol/l vs 15.1 +/- 3.3 mmol/l p < 0.05) and L3 visceral fat was greater (238 +/- 70 cm2 vs 106 +/- 36 cm2 p < 0.01), although there were no differences in body mass index, L3 subcutaneous fat, waist to hip circumference ratio or age. In conclusion, visceral fat quantity correlates with insulin sensitivity and blood pressure in android obese diabetics with similar morphotype (comparable body mass index and waist to hip circumference ratio).

[Nocturnal hypoglycemia in insulin-dependent diabetics]. / Hypoglycémie nocturne du diabétique insulinodépendant.

OBJECTIVES: Repeated hypoglycaemia has been reported to impair recognition of subsequent hypoglycaemia with a high risk of severe hypoglycaemia. This intensified insulin therapy may be dangerous in insulin-dependent diabetes mellitus (IDDM) patients with unawareness of hypoglycaemia. METHODS: We assessed the incidence of nocturnal hypoglycaemia and the benefit of an additional bedtime snack in IDDM patients treated by 2 or 3 daily injections. Capillary blood glucose was measured by finger strip at 10 p.m. and plasma venous glycaemia was determined at 0, 2, 4 and 8 a.m. RESULTS: The study was composed of two phases. In the first phase, patients (n = 93) did not receive any snack at bedtime. Blood glucose fell to 2.75 mmol/l or less in 33%. Among the 40 patients with a 10 p.m. glycaemia of 9 mmol/l or less, 57.5% experienced nocturnal hypoglycaemia vs 15% of the 53 others. The second phase concerned 106 IDD patients. An additional bedtime snack was given when 10 p.m. blood glucose was 9 mmol/l or less. The incidence of hypoglycaemia fell to 32% (14 of 44 IDDM) i.e. a significant benefit of 44% (p < 0.01). However patients who received this additional bedtime snack had a slightly higher 8 a.m. glycaemia than those with 10 p.m. glycaemia at 9 mmol/l or less during the first phase (9.61 +/- 5.67 mmol/l vs 7.75 +/- 4.30 mmol/l) but this result is not significant. CONCLUSION: Prevention of nocturnal hypoglycaemia may be achieved in IDDM patients by bedtime glucose determination and an additional snack when glycaemia is 9 mmol/l or less.