Alleviating carbohydrate counting with a FiASP‐plus‐pramlintide closed‐loop delivery system (artificial pancreas): Feasibility and pilot studies

Abstract

Aim To assess whether a FiASP‐and‐pramlintide closed‐loop system has the potential to replace carbohydrate counting with a simple meal announcement (SMA) strategy (meal priming bolus without carbohydrate counting) without degrading glycaemic control compared with a FiASP closed‐loop system. Materials and Methods We conducted a 24‐hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP‐and‐pramlintide system with SMA. We conducted a subsequent 12‐day outpatient pilot study comparing a FiASP‐and‐placebo system with FCC, a FiASP‐and‐pramlintide system with SMA, and a FiASP‐and‐placebo system with SMA. Basal‐bolus FiASP‐and‐pramlintide were delivered at a fixed ratio (1 U:10 μg). Glycaemic outcomes were measured, surveys evaluated gastrointestinal symptoms and diabetes distress, and participant interviews helped establish a preliminary coding framework to assess user experience. Results Seven participants were included in the feasibility analysis. Time spent in 3.9‐10 mmol/L was similar between both interventions (81%‐84%). Four participants were included in the pilot analysis. Time spent in 3.9‐10 mmol/L was similar between the FiASP‐and‐placebo with FCC and FiASP‐and‐pramlintide with SMA interventions (70%), but was lower in the FiASP‐and‐placebo with SMA intervention (60%). Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions. Emotional distress was moderate at baseline, after the FiASP‐and‐placebo with FCC and SMA interventions, and fell after the FiASP‐and‐pramlintide with SMA intervention. SMA reportedly afforded participants flexibility and reduced mealtime concerns. Conclusions The FiASP‐and‐pramlintide system has the potential to substitute carbohydrate counting with SMA without degrading glucose control.

Performance of Fast-Acting Aspart Insulin as Compared to Aspart Insulin in Insulin Pump for Managing Type 1 Diabetes Mellitus: A Meta-Analysis

“…The study by Grosman et al [ 15 ] was excluded as it was done using a virtual patient simulation and not in real patients. The study by Tsoukas et al [ 16 ] was excluded as it used pramlintide along with FIAsp insulin in the insulin pump closed loop system. The details of the studies included in this meta-analysis have been elaborated in Table 1 .…”

“… Flowchart elaborating on study retrieval and inclusion in the meta-analysis. Reason 1: lack of a valid control group [ 14 ]; Reason 2: was a virtual simulated study [ 15 ]; Reason 3: pramlintide was used along with fast-acting aspart insulin [ 16 ]. …”

Emerging Diabetes Technologies: Continuous Glucose Monitors/Artificial Pancreases

“…Hyperglycemic excursions especially after meals, even in HCL systems, continues to be a problem. One of the ways to mitigate hyperglycemia after meals is to use pramlintide to reduce these excursions 205 , 206 . A study from researchers at Yale University proved that the use of pramlintide is possible in significantly reducing post-meal hyperglycemic excursions 207 .…”

The Evolution of Insulin Administration in Type 1 Diabetes

“…Use of faster-acting insulin analogs discussed above in HCL is underway [148] [149] [150] [151]. Faster acting insulins could potentially allow for simplification of meal bolusing or elimination of meal announcement all together [152]. DIY options (i.e.…”

“…Pramlintide co-administration with rapid-acting insulin in HCL systems has been demonstrated to mitigate meal-related glycemic excursions [165]. Co-administration of faster-acting insulin aspart and pramlintide with only simple meal announcement demonstrated feasibility, and the results of the non-inferiority trial to HCL with standard carbohydrate counting completed in February 2020 (NCT02814123) [152]. Liraglutide, a GLP-1 agonist, may reduce post-prandial glucose excursions and HbA1c in T1D but also may increase hypoglycemia and ketosis [166] [167], making it unlikely to gain widespread use in T1D management.…”