Treatment Satisfaction With Omnipod DASH in Adults With Type 1 Diabetes: A Nonblinded 1:1 Randomized Controlled Trial

Abstract

Context: Omnipod DASH Insulin Management System is a tubeless insulin pump that overcomes the physical inconveniences of conventional tubed insulin pump therapy (IPT).

Objective: We compared treatment satisfaction with Omnipod DASH System to usual care (multiple daily injections [MDIs] or tubed IPT) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG).

Methods: Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from 4 diabetes centers in Australia were randomly assigned in a 1:1 nonblinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension during which all participants used the device. The primary outcome was treatment satisfaction assessed by change in Diabetes Technology Questionnaire "current" (ΔDTQ-current) score at 12 weeks (study end). Secondary outcomes included ΔDTQ-current following extension and other participant-reported outcomes (PROs) measuring quality of life, burden of disease treatment, and glycemic and device-related outcomes at 12 weeks (study end) and 24 weeks (end extension).

Results: Treatment satisfaction improved more in the Omnipod group vs the Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs 0.0 [12.8]; P < .001) at study end. Significantly greater improvements in other PROs and glycated hemoglobin A1c were also observed. Improvements in DTQ-current and other PROs comparing study end and end extension were similar. While percentage in time in range change from baseline did not differ at study end (-2.0 [12.7] %), it was significantly greater at end extension (5.6 [10.9] %; P = .016).

Conclusion: The Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG that was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed.

Keywords: Omnipod DASH system; quality of life; treatment satisfaction; tubeless insulin pump therapy.

Figure 1.

Study design.

Figure 2.

Flowchart of study participants. CGM, continuous glucose monitor.

Figure 3.

Mean change in Diabetes Technology Questionnaire (DTQ)-current score from baseline to study end. *Statistically significant difference in the mean change in the DTQ-current score between Omnipod and Usual Care groups. A higher score indicates more improvement in treatment satisfaction. Details of questions and responses are demonstrated in Fig. 4.

Figure 4.

Mean change in Diabetes Technology Questionnaire (DTQ)-current score from baseline to study end with details of question. **Statistically significant difference in the mean change in the DTQ-current score between Omnipod and Usual Care groups.

Figure 5.

Questionnaire data at baseline (0), end of study (12W), and end of extension phase (24W). A, Diabetes Technology Questionnaire (DTQ)-current; B, DTQ-change; C, Diabetes Medication System Rating Questionnaire Short-Form (DMSRQ-SF); D, System Usability Scale (SUS); E, User Experience Questionnaire (UEQ) (Omnipod group); F, UEQ (Usual Care group). Orange bars: Omnipod. Blue bars: Usual care. P less than .05 is considered statistically significant. Higher scores indicate more positive outcomes.

Figure 6.

Questionnaire data at baseline (0), end of study (12W), and end of extension phase (24W). A, Problem Areas in Diabetes (PAID); B, Hypoglycemia Fear Survey Short-Form (HFS-II-SF); C, Pittsburgh Sleep Quality Index (PSQI). Orange bars: Omnipod. Blue bars: Usual care. P less than .05 is considered statistically significant. Lower scores indicate more positive outcomes.