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.