Quality indicators for the prevention of type 2 diabetes in Europe--IMAGE.

BACKGROUND: The marked increase of type 2 diabetes necessitates active development and implementation of efficient prevention programs. A European level action has been taken by launching the IMAGE project to unify and improve the various prevention management concepts, which currently exist within the EU. This report describes the background and the methods used in the development of the IMAGE project quality indicators for diabetes primary prevention programs. It is targeted to the persons responsible for diabetes prevention at different levels of the health care systems. METHODS: Development of the quality indicators was conducted by a group of specialists representing different professional groups from several European countries. Indicators and measurement recommendations were produced by the expert group in consensus meetings and further developed by combining evidence and expert opinion. RESULTS: The quality indicators were developed for different prevention strategies: population level prevention strategy, screening for high risk, and high risk prevention strategy. Totally, 22 quality indicators were generated. They constitute the minimum level of quality assurance recommended for diabetes prevention programs. In addition, 20 scientific evaluation indicators with measurement standards were produced. These micro level indicators describe measurements, which should be used if evaluation, reporting, and scientific analysis are planned. CONCLUSIONS: We hope that these quality tools together with the IMAGE guidelines will provide a useful tool for improving the quality of diabetes prevention in Europe and make different prevention approaches comparable.

Clinical outcomes of pregnancy in women with type 1 diabetes(1).

OBJECTIVE: To evaluate predictors of neonatal hypoglycemia and macrosomia in 107 consecutive pregnancies in type 1 diabetic women. METHODS: We conducted a case record analysis of singleton type 1 diabetic pregnancies between January 1994 and January 1999 following institution of standardized management. RESULTS: The duration of diabetes in the women was 12.9 +/- 6.8 years, and 44 were primigravidas. The mean HbA1c throughout pregnancy was 7.2 +/- 0.8%. There was no relationship between neonatal blood glucose (checked before the second feed) and HbA1c at any point in pregnancy or mean pregnancy HbA1c (R = 0.20, P >.1). However, there was a negative correlation between neonatal blood glucose and maternal blood glucose during labor (R = -0.33, P <.001). When maternal blood glucose during labor was greater than 8 mM (144 mg/dL), neonatal blood glucose was usually less than 2.5 mM (mean 1.7 +/- 0.4 mM or 31 mg/dL). There was no relationship between mean HbA1c and birth weight (R = 0.02, P >.1) or between maximum insulin dose and birth weight (R = 0.09, P >.1). Fetal abdominal circumference measured by ultrasound at 34 weeks correlated strongly with birth weight (R = 0.72, P <.001). CONCLUSION: Neonatal hypoglycemia correlates with maternal hyperglycemia in labor, not with HbA1c during pregnancy. Macrosomia does not correlate with HbA1c during pregnancy.

Episodic hyperglycaemia in pregnant women with well-controlled Type 1 diabetes mellitus: a major potential factor underlying macrosomia.

AIMS: To test the common assumption that pregnant women who are sufficiently motivated to achieve very good HbA1c levels will record home blood glucose data accurately. METHODS: A new device was used to download information from electronic blood glucose meters to assess the extent of selectivity in patient glucose diary-keeping. RESULTS: In an index case, a woman with excellent ambient HbA1c (5.9%; upper limit of normal 6.1%) was observed to have 68% of preprandial blood glucose readings above the target range of 3.5-6.5 mmol/l and a mean (+/- SD) level of 8.9+/-3.9 mmol/l in the corresponding period. No such impression was conveyed by the home monitoring diary. Six pregnant women with well controlled Type 1 diabetes (mean HbA1c 6.6+/-0.2%) exhibited between 42 and 68% of preprandial readings above the target range. CONCLUSIONS: The frequency of hyperglycaemia has hitherto been underestimated in well controlled pregnant women whose near-perfect home monitoring record is apparently corroborated by near-normal HbA1c levels. These observations provide a hypothesis for understanding of the disappointing continuance of macrosomia despite excellent HbA1c levels throughout pregnancy.

Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice.

AIMS: To evaluate the outcome of two specific changes in the policy of managing pregnancy in Type 1 diabetes over a 5-year period. The need for change had been identified following an audit in the previous 5-year period: firstly, the need for intensive effort to improve the uptake of pre-pregnancy counselling; secondly, a modest relaxation of the targets for blood glucose control during labour to minimize the risk of maternal hypoglycaemia. METHODS: Data were collated from maternal and neonatal case notes from all women with Type 1 diabetes mellitus managed by Newcastle obstetric services between August 1989 and July 1994 (n = 80), comparing data with 40 such women looked after between November 1985 and July 1989. RESULTS: The age of the women, blood glucose control during pregnancy, gestation at delivery, and birth weight were similar in the 5-year period under study to those previously reported for the first study period. Mean blood glucose in labour for Period 2 was 5.5 +/- 0.6 mmol/l, exactly 1.0 mmol/l higher than the mean blood glucose achieved in labour for Period 1. As a consequence, only 22.5% women (18/80) experienced one or more episodes of blood glucose less than 3.0 mmol/l compared with 40.0% women in Period 1 (16/40) (P < 0.01). There was no effect of maternal blood glucose on neonatal blood glucose provided the former was within the range 4-8 mmol/l during labour. However, if maternal blood glucose was over 10 mmol/l, the infant's blood glucose was always low (1.3 +/- 0.8 vs. 2.5 +/- 1.5 P < 0.02). Macrosomia (over the 90th percentile for gestational age) was observed in 43.1% of infants in Period 1, and the mean birth weight was not different from Period 1. In the initial 5-year period 27.5% (11/40) women received specific pre-pregnancy care for their diabetes, compared with 21.3% (17/80) in Period 2 despite the intensive programme of education. There were six cases of congenital abnormality and two antepartum deaths (10% adverse outcome). CONCLUSIONS: The target range for blood glucose control in labour of 4-7 mmol/l minimizes maternal hypoglycaemia in labour and the data indicate that an upper limit of 8 mmol/l would not increase the risk of neonatal hypoglycaemia. Fresh thought is required about the matter of preventing congenital abnormalities by achieving better pre-pregnancy and peri-conception blood glucose control.

Insulin regimens for the non-insulin dependent: impact on diurnal metabolic state and quality of life.

A randomized prospective study was conducted to determine whether the insulin regimen for NIDDM subjects poorly controlled on oral therapy should be designed primarily to control basal metabolism or to control mealtime hyperglycaemia. Grossly obese subjects were excluded. After a 2-month run-in phase involving intensive education, subjects were randomized to therapy with twice daily isophane or three times daily soluble insulin. Both Protaphane and Actrapid brought about similar improvement in HbA1 (9.5 +/- 0.5 and 9.7 +/- 0.4%) compared with baseline (11.7 +/- 0.5%; p < 0.001). Diurnal blood glucose profiles showed that despite the good post-prandial control achieved by pre-meal soluble insulin, loss of control occurred overnight, resulting in higher fasting blood glucose levels compared with Protaphane therapy (8.0 +/- 0.8 vs 10.6 +/- 0.8 mmol l-1; p < 0.05). The overall rate of hypoglycaemia was 0.44 patient-1 year-1. Thirty-two mild hypoglycaemic episodes occurred on Protaphane therapy and 79 on Actrapid therapy. Using formal psychometric tests it was shown that insulin therapy was associated with improved treatment satisfaction and that this was greater on Protaphane therapy (p < 0.05). Overall well-being increased similarly in the two groups. All subjects wished to continue with insulin therapy after the conclusion of the study. The insulin regimen for moderately or poorly controlled non-insulin-dependent diabetes should primarily be designed to correct the basal insulin deficiency rather than to mimic normal meal-induced insulin secretion.