The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: Results of a randomized trial

Abstract

Objective

In a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems.

Methods

The study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1 ± 13.5 vs. 45.9 ± 13.1 years, p = .716; diabetes duration 18.8 ± 12.3 vs. 19.8 ± 13.4 years, p = .615; BMI 26.5 ± 4.6 vs. 27.5 ± 5.0 kg/m², p = .236; HbA1c 8.3 ± 1.1 vs. 8.1 ± 1.0%, p = .236).

Results

At follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (Δ −0.4 ± 1.0% vs. Δ 0.0 ± 0.6%; p = .012). Also, diabetes-related distress (Δ −0.3 ± 0.7 vs. −0.1 ± 0.4, p = .032) and dissatisfaction with diabetes treatment (Δ −3.3 ± 6.9 vs. −1.9 ± 5.6, p = .024) decreased more in PRIMAS. Diabetes empowerment (Δ 2.6 ± 5.9 vs. 0.8 ± 5.1, p = .037) and diabetes self-efficacy (Δ 1.4 ± 3.6 vs. 0.2 ± 4.0, p = .013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups.

Conclusion

PRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy.

Introduction

In the US and in Europe approximately 3–5 million people are suffering from type 1 diabetes [1], [2]. There is sufficient evidence that achieving a near normal glycaemic control by an intensive insulin treatment can prevent micro-vascular complications in people with type 1 diabetes [3] as well as macro-vascular complications [4]. However, the improvement of glycaemic control in type 1 diabetes was often associated with an increased risk of severe hypoglycaemia [5], [6].

Maintaining a balance between prevention of long-term complications and the immediate risk of hypoglycaemia is a complex task requiring blood glucose self-monitoring several times a day, adjusting insulin doses according to current blood glucose levels, planned carbohydrate consumption and/or planned physical activity. Also living with a chronic lifelong disease with an uncertain long-term prognosis can be associated with emotional distress [7] and a negative impact on psychological well-being [8].

Structured diabetes education, equipping people with type 1 diabetes with the necessary knowledge and skills for the above mentioned tasks has therefore become an essential element in the management of type 1 diabetes mellitus. The most common model used for type 1 diabetes education in Europe is the structured diabetes teaching and treatment programme (DTTP). This programme was already established in 1978 [9].

In spite of the early establishment of type 1 diabetes education the empirical support for the efficacy of type 1 diabetes education is rather weak due to a lack of randomized trials. Most of the evidence about the efficacy of type 1 diabetes education originates from uncontrolled pre-post-comparisons [9], [10] or controlled but not randomized studies [11], [12] showing an improvement of 0.3–2.8 percentage points of HbA1c.

There are only two randomized trials about the efficacy of diabetes education programmes in type 1 diabetes. Within the Stockholm Diabetes Intervention Study, type 1 diabetic patients in the intensive care group received individual counselling about diabetes, not a structured diabetes education programme, whereas the control group differed considerably from the intervention group with regard to access to frequency of clinical visits and telephone counselling [13]. Therefore, it is difficult to disentangle the specific impact of diabetes education from a more intensive diabetes care. There was no “attention control”. The other randomized trial was the DAFNE study. The DAFNE training course, a British adaptation of the original DTTP, was powered to show a beneficial effect on HbA1c after a 6-month follow-up. It showed a significant reduction of HbA1c from 9.4% to 8.4% in the intervention group, whereas glycaemic control of the waiting control group remained unchanged after 6 month (HbA1c from 9.3% to 9.5%) [14]. However, structured education was compared with a waiting control group, thus also lacking attention control. An intensified insulin therapy was initiated in the intervention group parallel to the structured diabetes education. Thus, the internal validity of this trial can be challenged for the lack of attention control and the lack of control for effects of intensive insulin treatment.

In summary there is a lack of empirical evidence even for the short-term efficacy of structured diabetes education in type 1 diabetic patients due to non-randomized trials or randomized trials with considerable problems regarding their internal validity.

Another problem concerns the concept of diabetes education in people with type 1 diabetes. Whereas diabetes education concepts in type 2 diabetes have evolved from primarily knowledge and skill focused programmes to empowerment- and self-management-cantered concepts [15], [16], [17], remained the concept of education programmes for people with type 1 diabetes has remained knowledge- and skill-cantered only. The above mentioned DTTP focuses rather on the technical than on the emotional aspects of living with diabetes. Therefore, further evaluation of other available models of education for people with type 1 diabetes should be undertaken [18].

A new structured education programme named PRIMAS (Programme for diabetes education and treatment for a self-determined living with type 1 diabetes) was therefore developed for type 1 diabetic patients. This structured education programme focuses on the empowerment of type 1 diabetic patients, enabling them to make informed judgments and choices about their own diabetes care. Barriers to an optimal diabetes treatment and personal attitudes of living with diabetes are also topics of the lessons as well as practical aspects of insulin therapy.

In this randomized study the efficacy of the newly developed PRIMAS education programme was examined by head to head comparison with the well-established DTTP. Since the DTTP has shown its efficacy in improving glycaemic control [9], [14], the primary objective of this study was to show the non-inferiority of the new PRIMAS education programme compared to the established DTTP education programme with regard to glycaemic control. In case of non-inferiority, the superiority of the PRIMAS programme with regard to glycaemic control is tested. Secondary outcome variables were the effects on diabetes-related distress, depressive symptoms, diabetes empowerment, self-efficacy for diabetes treatment, diabetes knowledge, self-care behaviour, satisfaction with insulin therapy, the incidence of severe hypoglycaemic episodes, and satisfaction with the education programme itself.