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

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.

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±5.0kg/m(2), p=.236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=.236).

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.

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.