Table 1

Design features, populations enrolled, and selected outcomes of three proof-of-concept studies of coadministration of insulin and pramlintide for type 1 diabetes. Mean values are shown.

CharacteristicStudy
Sherr et al. (15)Riddle et al. (16)Haidar et al. (17)
Number of participants102627
Age (years)204135
Duration T1D (years)92423
Baseline HbA1c (%)7.28.17.8
Duration of intervention24 h24 h24 h
ComparisonRapid insulin CSII vs. rapid insulin CSII + pramlintide mealtime injectionsRegular insulin CSII + placebo CSI vs. regular insulin CSII + pramlintide CSIRapid insulin CSII vs. rapid insulin CSII + pramlintide CSI
Pram/insulin ratio (μg/unit)96
Dosing algorithmAutomated closed-loop basal without bolusesFixed basal rate and fixed bolus doses selected by investigatorsAdaptive closed-loop basal and bolus administered by investigators
Bolus pram dose (μg)
 Breakfast6053Mean all meals 34
 Lunch6045Mean all meals 34
 Dinner6068Mean all meals 34
Total daily insulin dose (units)
 CSII alone38.838.4
 CSII + pram35.237.9
Mean CGM glucose
 CSII alone (mg/dL)166175144
 CSII alone (mmol/L)9.29.78.0
 CSII + pram (mg/dL)160153133
 CSII + pram (mmol/L)8.98.57.4
 Difference (mg/dL)−6−22−11
 Difference (mmol/L)−0.3−1.2−0.6
P for differenceP = 0.08P = 0.012P = 0.001
TIR (70–180 mg/dL), 24 h
 CSII alone50.274
 CSII + pram61.584
P for differenceP = 0.046P = 0.001
TIR (70–180 mg/dL), 0800–2300 h
 CSII alone59.763
 CSII + pram71.078
P for differenceP = 0.004P = 0.0004
  • CSI, continuous subcutaneous infusion; pram, pramlintide; T1D, type 1 diabetes.