The Särimner diabetes simulator--a look in the rear view mirror.

BACKGROUND: At the end of the 1980s, the Department of Pediatrics at Linköping University, Linköping, Sweden developed a computerized diabetes simulator. The main purpose was to allow teenagers with Type 1 diabetes to experiment with food, exercise, and insulin without the risk of inconvenience. The aim of this paper is to discuss experiences from the previous work with teenagers on the Särimner diabetes simulator. METHODS AND RESULTS: In 1991, shortly before Sweden became computerized, the impact of the simulator was evaluated in a study with 11 teenagers. Improvements were seen in a few individuals regarding locus of control, self-esteem, diabetes knowledge, and diabetes-related stress, but could not be shown on a group level. The simulator was used for longer periods at some clinics, also by individual health professionals and in a diabetes camp, but support for further development has been lacking. It was also used in modeling projects of Type 2 diabetes and obesity. CONCLUSIONS: Proactive pedagogic measures may find it hard to compete with corrective technological measures since their effectiveness is more difficult to prove by scientific methods. Nevertheless, they are needed together with other methods to improve understanding and motivation in the treatment of Type 1 diabetes.

Development of a PC-based diabetes simulator in collaboration with teenagers with type 1 diabetes.

BACKGROUND: The main aim of this study was to develop and test in a pilot study a PC-based interactive diabetes simulator prototype as a part of future Internet-based support systems for young teenagers and their families. A second aim was to gain experience in user-centered design (UCD) methods applied to such subjects. METHODS: Using UCD methods, a computer scientist participated in iterative user group sessions involving teenagers with Type 1 diabetes 13-17 years old and parents. Input was transformed into a requirements specification by the computer scientist and advisors. This was followed by gradual prototype development based on a previously developed mathematical core. Individual test sessions were followed by a pilot study with five subjects testing a prototype. The process was evaluated by registration of flow and content of input and opinions from expert advisors. RESULTS: It was initially difficult to motivate teenagers to participate. User group discussion topics ranged from concrete to more academic matters. The issue of a simulator created active discussions among parents and teenagers. A large amount of input was generated from discussions among the teenagers. Individual test runs generated useful input. A pilot study suggested that the gradually elaborated software was functional. CONCLUSIONS: A PC-based diabetes simulator may create substantial interest among teenagers and parents, and the prototype seems worthy of further development and studies. UCD methods may generate significant input for computer support system design work and contribute to a functional design. Teenager involvement in design work may require time, patience, and flexibility.

Seasonal variation in the diagnosis of type 1 diabetes in south-east Sweden.

With the aim to survey the seasonal pattern of diagnosis of type 1 diabetes we included all 1903 children <16 years of age and who had been diagnosed with type 1 diabetes between 1977 and 2001 in the south-east of Sweden. To investigate the seasonal pattern a mixture of two cosine functions was included in a logistic regression model. There was a clear seasonal variation over the years (p<0.001). Children in the oldest age group (11-15 years) showed the most obvious seasonal variation (p<0.001). Children with a short duration of symptoms had about the same seasonal variation as children with a long duration. Both children with and without an infection 3 months prior to diagnosis showed significant seasonal variation (p<0.001) although the seasonal pattern differed between the two groups (p<0.001). As the incidence of diabetes increased during the 25 years the study period was divided into periods of 5 years and it was only during the two last periods that significant seasonal variation occurred. There is a clear seasonal variation in diagnosis of type 1 diagnosis in children and the results suggest that children with a less aggressive disease process at diagnosis were most responsible for this variation. Children with and without prior infection showed a different seasonal pattern.

Prevention of severe hypoglycaemia in type I diabetes: a randomised controlled population study.

AIMS: To investigate use of targeted self study material in type I diabetes patient education regarding dissemination, perceived patient benefit, and prevention of severe hypoglycaemia. METHODS: In a randomised 1:1:1 controlled study, 332 patients with type I diabetes (aged 2.6-18.9 years) were studied; 313 completed clinical follow up, 261 completed endpoint questionnaire. The intervention group received videotapes and a brochure designed to review skills for self control and treatment, aimed at preventing severe hypoglycaemia. Two control groups received a videotape and brochure with general diabetes information, or traditional treatment only, respectively. RESULTS: Yearly incidence of severe hypoglycaemia decreased from 42% to 27% in the intervention group, but not in controls. HbA1c remained unchanged. Levels of use ranged from 1 to 20 times (median 2); 40-49% had shown the materials to friends, relatives, school staff, sports coaches, etc (there was little difference between intervention and control groups). Higher benefit and learning levels resulted from the intervention material, especially in patients with severe hypoglycaemia. CONCLUSIONS: Mass distributed pedagogical devices such as high quality video programmes and brochures may contribute to the prevention of severe hypoglycaemia. Such self study materials can reach high dissemination levels and constitute a cost effective complement to regular visits to a diabetes team and to other types of education. The findings may have implications for other topics, other ages, and other diagnosis groups.

Short-term effects of severe hypoglycaemia in children and adolescents with type 1 diabetes. A cost-of-illness study.

UNLABELLED: The aim of this study was to describe costs and other short-term effects of severe hypoglycaemia in children and adolescents with type 1 diabetes. The study comprised a geographic population of 129 patients <19 y of age with families prospectively registering detailed data after self-reported severe hypoglycaemia. In the period Jan.-Dec. 1998, 16 events were reported with unconsciousness and 95 events without unconsciousness but needing the assistance of another person. Of all events, 20-30% had effects requiring the assistance of people other than parents, school absence, parents' absence from work, extra transport and/or telephone calls. Patient (family) activities were cancelled after 10% (5%) of events. Increased worry for parents was reported after 8% and poor sleep after 7% of events. Hospital visits took place at 5% and hospitalizations at 3% of all events. Patients with severe hypoglycaemia indicated lower global quality of life (p=0.0114). The average socio-economic burden for events of severe hypoglycaemia was estimated at EURO 17,400 yearly per 100 type 1 diabetes patients. Average cost was estimated at EURO 239 per event of severe hypoglycaemia with unconsciousness or EURO 478 yearly per patient with unconsciousness, and EURO 63 per event of severe hypoglycaemia without unconsciousness but needing assistance from another person or EURO 307 yearly per patient in this category. These are conservative estimates and do not include unpaid time and other intangibles, possible road traffic accidents, disabling or premature deaths. CONCLUSIONS: The results suggest the potential for socio-economic savings and increased quality of life for patients and families from severe hypoglycaemia prevention programs.

Seasonal variation of HbA1c in intensive treatment of children with type 1 diabetes.

OBJECTIVE: The aim of this study was to measure whether there is a seasonal variation in glycosylated haemoglobin concentrations and insulin dose used in the intensive treatment of children with type 1 diabetes, and whether such variation is related to severe hypoglycaemia. PATIENTS: A geographic population of 114 intensively treated type 1 diabetic patients < 19 years of age, mean 12.7 (SD 4.3) years, with diabetes onset before 1995, were studied in a cohort 1995-96. METHODS: HbA1c, insulin doses and severe hypoglycaemia were registered at regular visits scheduled quarterly, but not standardised in time. Seasonal mean values were calculated for HbA1c and insulin dose. RESULTS: Lower HbA1c was seen in spring and summer, and higher in autumn and winter (p=0.023). Patients reporting severe hypoglycaemia had a seasonal variation in HbA1c (p=0.019) and a tendency to seasonal variation in insulin dose, while patients not reporting severe hypoglycaemia did not vary in HbA1c or insulin dose. CONCLUSIONS: Self-control and adjustment of insulin doses to seasonal change need to be improved also in intensively treated children, with regard to the risk for worsened metabolic control after the summer and increased severe hypoglycaemia in spring and early summer. The findings have important implications for design of short-term studies of metabolic control.

Adverse events in intensively treated children and adolescents with type 1 diabetes.

The main objective of this study was to examine the relation between adverse events and degree of metabolic control and multiple-dose treatment. A total of 139 children, aged between 1 and 18 y, prospectively registered severe hypoglycaemia with or without unconsciousness, as well as hospitalized ketoacidosis, during 1994-95. Treatment from onset was multiple-dose insulin (> 95% > or = 4 doses) combined with intense training and psychosocial support. Median HbA1c was 6.9% (ref. 3.6-5.4%). The incidence of severe hypoglycaemia with unconsciousness was 0.17 events per patient-year, having decreased from the 1970s to the 1990s, parallel to a change from 1-2 to > or = 4 doses per day. There was no correlation or association to the year mean HbA1c for severe hypoglycaemia. Severe hypoglycaemic episodes in 1995 correlated to severe hypoglycaemic episodes in 1994 (r=0.38; p<0.0001). Severe hypoglycaemia with unconsciousness increased during the spring season, and according to case records the assumed causes were mainly mistakes with insulin, food and exercise. Ketoacidosis was rare: 0.015 episodes per patient-year. We conclude that multiple-dose insulin therapy from the very onset of diabetes, combined with adequate self-control, active problem-based training and psycho-social support, may limit severe hypoglycaemia and ketoacidosis. Strategies aimed at minimizing severe hypoglycaemia without compromising metabolic control need to be evaluated.

Hypoglycaemia during intensified insulin therapy of children and adolescents.

Good metabolic control prevents or at least postpones late vascular complications, but several studies indicate that such good metabolic control cannot be reached without simultaneous increase in the incidence of severe hypoglycaemia. We have been able to reduce late complications through multiple insulin therapy adjusted on the basis of active self control combined with active psychosocial support and education. A prospective regular registration of all hypoglycaemic incidents in about 130 diabetic children and adolescents shows that in spite of reasonably good HbA1c values (mean and median 6.9%, corresponding to 7.9% with the DCCT method), we have less incidence of severe hypoglycaemia (13-17 per 100 patient years) than reported in other recent studies (20-25 per 100 patient years). We saw no correlation between HbA1c and severe hypoglycaemia, but most hypoglycaemia was caused by mistake or reasons not related to degree of metabolic control. Our conclusion is that there is no inevitable relation-ship between low HbA1c and hypoglycaemia. Instead hypoglycaemia should be prevented parallel to and in the same way as we try to reach good metabolic control.

Severe hypoglycemia in children with IDDM. A prospective population study, 1992-1994.

OBJECTIVE: Is an increased incidence of severe hypoglycemia an unavoidable effect of improved metabolic control? And, if so, to what extent? RESEARCH DESIGN AND METHODS: In 1992-1994, severe hypoglycemia was prospectively registered in our intensively treated IDDM population, 146 children 1-18 years of age with > 90% of the patients on > or = 4 insulin injections per day. The two categories, "severe hypoglycemia with unconsciousness" (U hypoglycemia) and "severe hypoglycemia without unconsciousness but needing the assistance of another person" (NU hypoglycemia), were analyzed in relation to yearly mean HbAlc levels, insulin doses and proportion of short-acting insulin, age at onset, duration of diabetes, age, sex, and weight-to-height ratio. RESULTS: Yearly mean HbAlc levels improved from 8.1 +/- 1.6% in 1992 to 6.9 +/- 1.3% in 1994. The yearly incidence of U hypoglycemia was 0.15-0.19 events per patient-year, seen in 10-16% of patients, showing no significant increase from 1992-1994. For NU hypoglycemia, slightly increasing figures from 1.01 to 1.26 events per patient-year, seen in 27-38% of patients yearly, were reported. There was no significant correlation between severe (U or NU) hypoglycemia and HbAlc, but still an association was seen in certain calculations. In multiple regression analysis, U hypoglycemia was not related to any factor, but the square root of the rate of NU hypoglycemia was related to lower HbAlc levels (P = 0.0003), higher insulin doses (IU.kg-1.24 h-1) (P = 0.0024), and a lower proportion of short-acting insulin out of the total daily insulin dose (P = 0.031). CONCLUSIONS: Multiple-dose insulin therapy with rather low yearly mean HbAlc values causes a slight increase of NU hypoglycemia but no increase of U hypoglycemia in our population of children with IDDM. Near physiological HbAlc levels may be achieved without any pronounced risk of increasing the incidence of severe hypoglycemia when multiple-injection insulin therapy is combined with adequate self-control based on psychosocial support and active education.