Fig 1.
Flowchart for the GLUMIT-DG study.
This figure shows the Flowchart for patient recruitment for the GLUMIT-DG study, which follows a non-randomized trial design. A TREND checklist accompanies this Flowchart as the S1 File in the Supplemental Information section.
Fig 2.
The study design is shown. After an initial screening phase (up to 3 visits over up to 8 weeks), a run-in phase (up to 4 visits over up to 8 weeks) was conducted. The formal treatment phase consisted of 6 study visits over 24 weeks when CSII and CGM were used together to optimize glycemic control.
Table 1.
Patient characteristics at screening.
Table 2.
Primary safety outcome during screening/run-in vs. treatment phases—Weekly combined mild, moderate, and severe hypoglycemic episodes.
Table 3.
Serious adverse events.
Fig 3.
Effects of CSII plus CGM on glycemic parameters are shown.
Treatment elicited significant reductions in hemoglobin A1c at 12 and 24 weeks of treatment compared to screening values (A). CGM readings revealed reductions in time in both hypo- and hyperglycemia with treatment at 24 weeks (blue) compared to the screening phase (orange) (B).
Table 4.
Frequencies of CGM glycemic excursions.
Table 5.
Characteristics of glycemic excursions.
Table 6.
Effect of CSII plus CGM treatment on gastroparesis symptoms, quality of life, and meal tolerance.