A detailed examination of the clinical terms and concepts required for communication by electronic messages in diabetes care.

The wider electronic exchange of clinical information between heterogeneous information systems in the delivery of diabetes care demands a common structure in the form of a message standard. A European Standard electronic diabetes message is being developed in conjunction with CEN TC251. This paper describes the methodologies that the 1998 DO IT Workshop has used to identify potential areas of difficulty in the design and implementation of the preliminary message model. To facilitate implementation and to avoid ambiguity in electronic messaging it is particularly important that there is standardisation of the definitions of the clinical terms specifically used in diabetes care across systems. Comprehensive lists of such terms to describe all areas of diabetes care do not exist and there is a lack of harmonisation of definitions in many areas. Thus, to better understand the user requirements of diabetes messaging several approaches were adopted. A review of the clinical terms and concepts contained in pre-existing datasets was undertaken with detailed study of a number of specific areas of diabetes care, analysing the conceptual structure of all the clinical terms that they comprised. Consideration of several worst case clinical scenarios for messages to communicate was also made to identify deficiencies in the message structure. This activity confirmed the importance of creating a Standard for a superset or thesaurus of diabetes specific terms, with appropriate definitions, to harmonise data communication in different IT systems to facilitate messaging. A substantial number of new terms were identified in the workshop and these will form an important first step to accomplishing a first draft superset once fully analysed. It was also apparent that certain specific areas within diabetes care, but most particularly in nursing, dietetics and podiatry, need urgent work to further develop the concepts and terms. This needs to be facilitated for an appropriate group of such professionals. To achieve such a Standard, continued co-operation with CEN/ISSS was recognised to be very important.

Using a double blind controlled clinical trial to evaluate the function of a Diabetes Advisory System: a feasible approach?

This paper assesses the feasibility of using a double blind controlled clinical trial to evaluate the function of a decision support system by applying such a design to the evaluation of a Diabetes Advisory System (DIAS). DIAS is based on a model of the human carbohydrate metabolism and is designed an interactive clinical tool, which can be used to predict the effects of changes in insulin dose or food intake on the blood glucose concentration in patients with insulin dependent diabetes. It can also be used to identify risk periods for hypoglycaemia. and to provide advice on insulin dose. The latter feature was evaluated in the present study. We believe double blind controlled clinical trials are prerequisites for clinical application of many decision support systems, and conclude that the present double blind controlled clinical trial is a suitable evaluation method for the function of DIAS.

A method to measure quality of diabetes treatment: results from an outpatient clinic.

It is essential for patients, hospital staff and hospital administrators to know the quality of hospital care. We have developed a system to evaluate the quality in an outpatient clinic. The aims of this study are: to develop a system for quality monitoring of outpatient diabetes care, to evaluate the effectiveness of this system and to develop procedures for feedback to the patients and the staff. In this paper we report on the results related to the first two aims. The metabolic control of diabetes mellitus is evaluated by measurement of serum HbA1c, serum triglyceride, serum total cholesterol, body weight and blood pressure, and the result is used in the calculation of a metabolic score. Diabetic nephropathy and retinopathy are evaluated once a year according to international classifications. The data were collected from 1 January to 31 December 1991. We were able to collect data on HbA1c in 94% of the diabetic patients, but we obtained data in only 46-75% of the patients for all other parameters. Concerning glycemic regulation, 52.3% of the insulin-dependent diabetes millitus patients and 41.5% of the non-insulin-dependent diabetes mellitus patients had poor regulation. The results for the other parameters included in the metabolic score were more satisfactory. There was a significant correlation between the number of days the patients were in hospital and the HbA1c value. In conclusion, the system enables us to determine the degree of metabolic regulation and regular evaluation of diabetic late complications. Through the measurement of outcome parameters we have discovered failure in process quality in our hospital department.

Contraception in women with IDDM. An epidemiological study.

OBJECTIVE: To study whether suitable contraceptive methods to women with diabetes mellitus in fact are applied. RESEARCH DESIGN AND METHODS: A questionnaire survey on the use of contraceptives in all 18-to-49-yr-old women (n = 261) with IDDM in Funen County, Denmark, and an age-comparable control group, (n = 287) was performed. Data were collected from 1987 to 1990. Response was achieved from 94% diabetic women and 88% control subjects. RESULTS: The overall use of contraception in diabetic women (77.1%) was almost identical to that of control subjects (73.6%). Compared with control subjects, significantly fewer diabetic women were using the OCP (P < 0.005) and partner sterilization (P < 0.05), whereas more diabetic women were sterilized (P < 0.0005). Among diabetic contraceptive users, the IUD, female sterilization, condoms, and the OCP each accounted for roughly 20%. Diabetic women using the OCP were predominantly young, and most had never been pregnant; approximately 20% of them used high-dose formulations. Sterilization was frequently used by older diabetic women, and most of these women had 2 or more children; 27% of the diabetic women using an IUD were nulligravidae. Further, 18% used a method with an unsuitable high failure rate. CONCLUSIONS: Our study demonstrates that diabetic women are not sufficiently advised concerning use of contraception.

Epidemiology of menarche and menstrual disturbances in an unselected group of women with insulin-dependent diabetes mellitus compared to controls.

To describe the age at menarche and the prevalence of menstrual disturbances in an unselected group of women with insulin-dependent diabetes mellitus compared to controls, we identified all women having debut of diabetes mellitus before the age of 30 yr and living in the County of Funen, Denmark on July 1, 1987 and being between 18 and 49 yr old. The women received a structured questionnaire inquiring information concerning menstrual conditions. An age comparable group of nondiabetic women was used as controls; 245 (94%) diabetic women and 253 (88%) controls answered the questionnaire. Among women with debut of diabetes before the age of 10 yr, the age at menarche was delayed 1 yr when comparing to controls (P less than 0.0001). During the past 6 months before answering the questionnaire, 8.2% of the diabetic women and 2.8% of the controls had experienced episodes of secondary amenorrhea (P less than 0.01). Corresponding figures for oligomenorrhea were 10.6% and 4.8% (P less than 0.02), for polymenorrhea 7.3% and 5.2% (NS), and for all types of menstrual disturbances 21.6% and 10.8%, respectively (P less than 0.005). Episodes of secondary amenorrhea occurring more than 6 months before answering the questionnaire had been experienced by 10.7% of the diabetic population vs. 4.8% of the controls (P less than 0.05); corresponding figures for primary amenorrhea were 4.9% and 1.2%, respectively (P less than 0.05). We conclude that the age at menarche among women having developed insulin-dependent diabetes mellitus before the age of 10 yr was delayed by 1 yr when compared to controls. The overall prevalence of menstrual disturbances is increased in diabetic women compared to nondiabetic controls.

Infertility and pregnancy outcome in an unselected group of women with insulin-dependent diabetes mellitus.

OBJECTIVES: The null hypothesis of this study is that infertility and pregnancy outcomes in women with insulin-dependent diabetes are identical to those of nondiabetic control subjects. STUDY DESIGN: A questionnaire survey comprising an unselected population of 18- to 49-year-old diabetic women and a comparable control group was performed. Reply rates were 94% (n = 245) and 88% (n = 253), respectively. RESULTS: Cumulative rates of pregnancies and involuntary infertility (17%) did not differ between the two groups. Diabetic women had significantly fewer pregnancies (1.4 vs 1.7) and fewer births per pregnancy than controls, and more diabetic women were nulliparous (48% vs 38%). Half of all diabetic pregnancies were planned. Diabetic women reported that their diabetes had a negative influence on their attitude toward having children. CONCLUSION: In insulin-dependent diabetic women the ability to conceive is normal, but diabetic women have fewer pregnancies and fewer births per pregnancy than controls.

Screening with zinc protoporphyrin for iron deficiency in non-anemic female blood donors.

Iron-depleted donors are at increased risk of developing anemia; if these donors could be identified by a screening test, iron supplementation or decreased donation frequency could be considered. Tests to determine serum ferritin, blood hemoglobin, and erythrocyte (Erc)-zinc protoporphyrin concentrations were examined in 679 consecutive female blood donors to identify donors with non-anemic iron deficiency. The test to determine serum ferritin is expensive and slow, whereas the two latter tests are rapid and less costly and could therefore be used for screening. Women in the fertile age groups had the lowest average serum ferritin values. In all, 93 women (13.7%) had depleted iron stores, as indicated by serum ferritin concentrations less than 14 micrograms/L. In these women, a much better correlation was found between Erc-zinc protoporphyrin and serum ferritin (rs = -0.49, P less than 0.001) than between blood hemoglobin and serum ferritin (rs = 0.31, P less than 0.01). These findings suggest that measurement of Erc-zinc protoporphyrin is superior to that of blood hemoglobin in identifying donors with non-anemic iron deficiency.

Delayed blood regeneration in lead exposure: an effect on reserve capacity.

Twenty-five lead-exposed Danish battery production workers and 25-age-matched controls were examined to evaluate subclinical effects on blood formation. Blood lead levels averaged 2.14 mumol/L and 0.35 mumol/L in the two groups; the lead workers also showed high levels of erythrocyte protoporphyrin, as compared to the controls. Otherwise, the hematological parameters indicated an appropriate iron status and no other deviations. From all subjects, 0.45 L of blood was bled as part of a normal blood donation. Five and 11 days later, reticulocyte counts were significantly higher in the control group than in the lead-exposed workers. On day 15, the lead workers showed a significant delay in blood regeneration, as evidenced by lower hemoglobin concentration, and erythrocyte and reticulocyte counts. The lead exposure in the present study was within legal limits, and lead-induced anemia would be expected only at much higher exposure levels. Thus, despite the normal hematological findings in the initial examination, the lead exposure caused a decreased reserve capacity for blood formation, and this effect became evident only after the blood loss.