Psychological and metabolic improvement after an outpatient teaching program for functional intensified insulin therapy (FIT)
Introduction
Recent advances in the treatment of diabetes have focused on quality-of-life outcomes as much as on biological outcome variables as retinopathy, nephropathy and neuropathy 1, 2, 3. The introduction of multiple daily insulin injection regimen and easy to use devices for the self-measurement of blood glucose level have provided the tools to improve metabolic control and flexibility of the insulin substitution 1, 2, 3, 4, 5. In the last decade various modes of `intensified insulin therapy' have been developed that differ mostly in the extent to which patients can modify freely the timing of meals and dietary restrictions. Under a regimen of conventional intensified insulin therapy, the patient usually takes blood glucose measurements prior to meals and adjusts the amount of rapidly acting insulin to actual blood glucose level and to the characteristics of the following meal. This varying amount of rapid acting insulin is combined with an evening and/or a morning injection of depot insulin. Even though this type of therapy substantially improved metabolic control by adjusting more precisely insulin substitution to calories and glucose intake, the impact of conventional intensified insulin therapy on daily life was substantial: the timing of meals, the composition of food had to be controlled precisely to avoid drops in blood glucose level between main meals and snacks had to be ingested in between. Improved knowledge with regard to the relationship between food-composition and insulin requirements allowed for a more liberal handling of the amount of food and the timing of meals. A systematic application of the more sophisticated knowledge concerning insulin requirements led to the so-called functional insulin therapy (FIT), which allows for an advanced individualized insulin substitution 3, 6, 7. Functional insulin therapy, however, requires an even more conscious management of insulin supply than conventional intensified insulin therapy. Patients have to keep track of their blood glucose level by frequent blood sugar measurements. They always need to be aware of their mental and physical activities and of their actual food intake in order to determine the amount of rapidly acting insulin necessary to correct blood glucose variations. This large amount of attention and mental effort required from patients who use FIT might add an additonal burden to the daily life of patients. The Diabetes Control and Complications Trial research group has already raised the important question whether quality of life might negatively be affected when patients intensify their insulin therapy [9]. It was found that the `average' patient does not get preoccupied with blood glucose control when he increases the number of measurements and the precision of his protocol. FIT, however, requires even more blood glucose measurements than the ones described in the DCCT trial, it asks for more treatment decisions than conventional intensified insulin therapy does. We were therefore concerned whether changing from conventional intensified therapy to functional insulin therapy, probably requiring more self-measurements per day, would have a negative impact on quality of life and other psychological characteristics. The following questions were investigated: Does FIT impact quality of life? Does FIT impact other psychological characteristics? Does FIT influence the individual concept of self-determination and self-responsibility by changing patient competence and control? Does FIT diminish the hierarchical distance between patient and physician?
Section snippets
Recruitment of participants
The training course in FIT was offered to all outpatients of the Division of Diabetology (n=250). This sample represents 50% of all type 1 diabetics in the City of Basel. All patients were treated with conventional intensified insulin therapy (three to four injections per day). They had received a training course lasting for 23–30 h about general issues in diabetes, metabolic control, food care, insulin injection technique, adjustment of insulin requirements to physical activity, intercurrent
Results
We investigated 43 patients with a mean age of 33±10 years and a mean duration of diabetes of 15±10 years. A total of 61% of the patients were women. There was no significant difference in dependent variables between men and women. The number of insulin injections did not change during the introduction of FIT. Also, there were no significant changes in basic insulin (19.4 vs 19.2 IU) nor in the total insulin doses per day (42.0 vs 39.4 IU). Body weight did not change.
Discussion
The main finding of the current investigation is that handing over expertise in the individualized assessment of insulin requirements from the physician to the patient does not deteriorate metabolic control. Instead, metabolic parameters have slightly improved. After 4 months of FIT therapy the hemoglobin A1c level was significantly lower than before FIT, but after 12 months the difference disappeared. This time course may be interpreted as an immediate study effect that disappeared during
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2009, Diabetes Research and Clinical PracticeCitation Excerpt :In contrast, in another population of patients with three or more episodes of severe hypoglycaemias, HbA1c decreased slightly from 7.4% to 7.2% at follow-up but the incidence of severe hypoglycaemia decreased substantially from 6.1 to 1.4 events/patient per year [13]. In Switzerland, the earlier FIT courses included a selected population of patients with an excellent HbA1c but a high rate of hypoglycaemia [4,14,21]. After the FIT courses, HbA1c was unchanged but the percentage of patients experiencing severe hypoglycaemic episodes was significantly reduced [4,14,21].