Little is known about the rates of acute complications when switching from MDI or traditional insulin pumps to tubeless insulin pump therapy. The German/Austrian Diabetes patients follow-up-registry (DPV) includes 2691 patients with type 1 (n=2640), type 2 (n=17) and LADA/other (n=34) diabetes types treated for 1.3±1.3 years with a tubeless insulin pump (Omnipod® Insulin Management System, Insulet Corp, Billerica, MA) since 2013. Patients with type 1 diabetes had a mean age of 12.3 year [IQR 9.6-15.0], diabetes duration 2.5 year [0.7-5.9], HbA1c 7.7% [6.8-8.3]. The prior treatment modality was 59.3% MDI, 37.5% other pump and 2.4% tubeless pump as initial therapy (0.3% unknown). Discontinuation of tubeless pump treatment in patients with type 1 diabetes was 7.3% and occurred after 0.7±0.9 mo. Despite the typical age-dependent increase in HbA1c in this primarily adolescent population, the rate of severe hypoglycemia (Level 3), hypoglycemic coma and DKA decreased between 29% to 76% with Omnipod System use compared to the year prior to treatment switch in the total cohort and type 1 patients with 3 year follow-up (n=835) (Table).
In conclusion, analysis of the DPV registry shows that use of the Omnipod System has high treatment retention rates in type 1 diabetes and is associated with low rates of severe hypoglycemia and DKA in this age-group prone to acute complications.
Three Year Outcomes with Omnipod System Use
| Variable (mean) | Total Cohort | Patients with 3 yr Follow-up | ||||||
| Post-Omnipod | Post-Omnipod | |||||||
| Pre-Omnipod (prior year) | 1 yr (n=2167) | 2 yr (n=1351) | 3 yr (n=848) | Pre-Omnipod (prior year) | 1 yr (n=835) | 2 yr (n=835) | 3 yr (n=835) | |
| Age, yr | 13.9 | 14.7 | 14.4 | 14.6 | 11.5 | 12.4 | 13.5 | 14.4 |
| BMI-SDS | 0.44 | 0.54 | 0.56 | 0.60 | 0.43 | 0.50 | 0.55 | 0.61 |
| Insulin dose, U/kg/d | 0.82 | 0.76 | 0.79 | 0.82 | 0.79 | 0.77 | 0.79 | 0.83 |
| HbA1c, % | 7.69 | 7.59 | 7.85 | 7.94 | 7.55 | 7.49 | 7.81 | 7.97 |
| Severe hypoglycemia (Level 3) patients affected per year, % | 5.2 | 5.5 | 4.3 | 3.7 | 5.7 | 7.2 | 4.7 | 3.6 |
| Severe hypoglycemia (coma) patients affected per year, % | 1.5 | 1.4 | 1.0 | 0.5 | 1.7 | 1.8 | 1.4 | 0.4 |
| DKA patients affected per year, % | 5.8 | 3.3 | 3.0 | 2.1 | 6.6 | 3.6 | 3.0 | 2.2 |
| Variable (mean) | Total Cohort | Patients with 3 yr Follow-up | ||||||
| Post-Omnipod | Post-Omnipod | |||||||
| Pre-Omnipod (prior year) | 1 yr (n=2167) | 2 yr (n=1351) | 3 yr (n=848) | Pre-Omnipod (prior year) | 1 yr (n=835) | 2 yr (n=835) | 3 yr (n=835) | |
| Age, yr | 13.9 | 14.7 | 14.4 | 14.6 | 11.5 | 12.4 | 13.5 | 14.4 |
| BMI-SDS | 0.44 | 0.54 | 0.56 | 0.60 | 0.43 | 0.50 | 0.55 | 0.61 |
| Insulin dose, U/kg/d | 0.82 | 0.76 | 0.79 | 0.82 | 0.79 | 0.77 | 0.79 | 0.83 |
| HbA1c, % | 7.69 | 7.59 | 7.85 | 7.94 | 7.55 | 7.49 | 7.81 | 7.97 |
| Severe hypoglycemia (Level 3) patients affected per year, % | 5.2 | 5.5 | 4.3 | 3.7 | 5.7 | 7.2 | 4.7 | 3.6 |
| Severe hypoglycemia (coma) patients affected per year, % | 1.5 | 1.4 | 1.0 | 0.5 | 1.7 | 1.8 | 1.4 | 0.4 |
| DKA patients affected per year, % | 5.8 | 3.3 | 3.0 | 2.1 | 6.6 | 3.6 | 3.0 | 2.2 |
T. Biester: Speaker's Bureau; Self; Medtronic, Ypsomed AG. T. Danne: Speaker's Bureau; Self; A. Menarini Diagnostics. Advisory Panel; Self; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Dexcom, Inc.. Research Support; Self; Eli Lilly and Company. Stock/Shareholder; Self; DreaMed Diabetes, Ltd.. Research Support; Self; Insulet Corporation. Speaker's Bureau; Self; Menarini Group. E. Bollow: None. A. Schwandt: None. B. Heidtmann: None. B. Rami-Merhar: Speaker's Bureau; Self; A. Menarini Diagnostics, Eli Lilly and Company, Medtronic MiniMed, Inc., Roche Diabetes Care Health and Digital Solutions. T. Haak: Speaker's Bureau; Self; Abbott. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions, Sanofi, Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company, AstraZeneca. R.W. Holl: None.
