Table 1: Randomised Controlled Studies Comparing CSII with MDI in Patients with Type 2 Diabetes.
| First Author/ Year (Reference) | Design | Number and Patient Characteristics (BMI, DD) | Anti-diabetic Treatment before CSII | Insulin Requirement before CSII (U/kg) | Baseline HbA1c (%) CSII versus MDI | Final HbA1c (%) CSII versus MDI | Weight gain (kg) CSII versus MDI | Type of Insulin Average Insulin Requirement | CGM data | Non-severe Hypoglycaemia Frequency |
|---|---|---|---|---|---|---|---|---|---|---|
| Raskin 20038 | Randomised parallel CSII versus MDI 24 weeks | n=127, BMI 32 DD: 12–14 years | Insulin+OHA 41 % Insulin only 59% | 0.69 versus 0.75 U/kg/d | 8.2 % versus 8 % 66 versus 64¶ | 7.6 % versus 7.5 % 60 versus 58¶ (NS) | +1.7 versus +0.8 (NS) | MDI/asp+NPH CSII/asp 0.6 versus 0.7 U/kg (NS) | NA | 54 % versus 59 % (NS) |
| Herman 20059 | Randomised parallel CSII versus MDI 48 weeks | n=98, BMI 32 DD: 15–17 years | Insulin+OHA 43% Insulin only 57% | NA | 8.4% versus 8.1% 68 versus 65¶ | 6.6 % versus 6.4 % 49 versus 46¶ (NS) | +2.1 versus +2.6 (NS) | MDI/lispro+glargine CSII/lispro 108 U/d | NA | 81 % versus 90 % (NS) |
| Berthe 200710 | Randomised cross-over CSII versus MDI* 2x12 weeks | n=17, BMI 33.7 DD: 16.8 years | 2 daily injections | 1 U/kg/d | 9 % | −1.3 versus −0.4 %* p<0.03 | No change in both groups | CSII/lispro MDI/lispro+NPHx31 U/kg/d stable in both groups | Hyperglycated AUC CSII<MDI no difference in hyperglycated AUC | 41 % versus 47 % |
| Wainstein 200511 | Randomised cross-over CSII versus MDI* 2x18 weeks | n=29, BMI 30–45 DD: NA | 2-3 daily injections | >1 U/kg/d | 10.2% and 10.3% 88 versus 89¶ (groups 1 and 2)* | −0.4 % versus +0.8 % (p<0.01) | −0.04 versus +0.09 | CSII/lispro MDI/ regular+NPH metformin both groups −15 U/d versus +20 U/d | Hyperglycated AUC CSII<MDI | 6 % versus 20 % (NS) |
| Reznik 201412 | Randomised parallel | n=331, BMI 33±7.2 DD: 15.1 ±8 years | Rapid and slow analogues ≥3 daily injection | 0.7–1.8 U/kg/d | 9±0.75 and 9±0.76 | 7.9±1.06 versus 8.6±1.24 (p<0.001) | +1.5 and +1.1 (P>0.1) | CSII/rapid analogue slow and rapid analogues metformin 70% both groups | 24-hour AUC CSII<MDI | 8.8 versus 5.1 mn/d |
*Patients were randomised to begin with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDIs) (groups 1 and 2, respectively);¶ mmol/mol. AUC = area under curve; BMI = body mass index; CGM = continuous glucose monitoring; DD = diabetes duration; HbA1c = haemoglobin; NS = not significant; ОНА = oral hypoglycaemic agents; NPH = neutral protamin Hagedorn; NA = not available.