Transition from MDI to pump therapy may be beneficial to a wide range of people with diabetes such as young children, newly diagnosed, switching to closed-loop therapy and more. At times the reverse transition is needed, such as during pump malfunction, or when a "pump holiday" is required. The Switch Advisor is a decision support system developed to ease, personalize and optimize the transition between MDI to pump therapy or vice versa.
Methods: The Switch Advisor was evaluated for safety in two feasibility, one arm studies. Each study included 4 weeks of data collection while participants used their regular treatment modality, then participants switched to the second mode of therapy based on algorithm recommendations. CGM related matrices were compared between the data collection period and 2 weeks after switching to the second mode of therapy. Primary outcomes were time in hypoglycemia < 54 mg/dl and time in range of 70-180 mg/dl.
Results: 11 participants [aged 22.8y (3.7), A1c 7.3% (0.8), and 56.5 (7.7) mmol/mol, mean (SD)] completed the first study of, transition from pump to MDI therapy. 12 participants [aged 12.7 (4.3), A1c 8.4 (0.9) and 68 (9.8) mmol/mol] completed the second study of, transition from MDI to pump therapy. Mean percent (SD) TIR 70-180 mg/dl was 62% (13) and time < 54 mg/dl was 3% (2) during pump therapy and 58% (9) and 4% (5) after switching to MDI, respectively (P=N.S). TIR 70-180 mg/dl was 50% (15) and time < 54 mg/dl was 3% (3) during MDI therapy and 63% (15) and 2% (3) after switching to pump therapy (P=0.01, P=N.S, respectively). TDD of insulin was 59 (24) U during pump therapy and 54 (26) U after switch to MDI (N=9) and 30 (18) U during MDI therapy and 33(14) U after switching to pump therapy (N=10). No serious adverse events occurred during both studies.
Conclusions: An automated algorithm to determine initial pump therapy settings and MDI was found to be feasible and safe. RCT studies are needed to confirm the results of these feasibility studies.
R. Nimri: Employee; Self; DreaMed Diabetes. Stock/Shareholder; Self; DreaMed Diabetes. I. Muller: Board Member; Self; DreaMed Diabetes. E. Atlas: Board Member; Self; DreaMed Diabetes. Employee; Self; DreaMed Diabetes. Stock/Shareholder; Self; DreaMed Diabetes. M. Phillip: Consultant; Self; Qulab Medical, RSP Systems A/S. Research Support; Self; JDRF. Stock/Shareholder; Self; NG Solutions Ltd, Nutriteen Professionals Ltd. Other Relationship; Self; AstraZeneca, Dexcom, Inc., DreaMed Diabetes, Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, OPKO Health, Inc., Pfizer Inc., Sanofi-Aventis.