Phase 2
Completed N=38
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Source: ClinicalTrials.gov NCT01073566 ↗Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Apr 2012
Primary outcomePrimary: Mean Daily Blood Glucose — 8.61; 9.02 mmol/L — p=0.098
Summary
The purpose of this study is to evaluate that Finesse, for prandial insulin bolusing when used in conjunction with basal insulin, achieves equivalent glycemic control when compared to multiple daily injections and to evaluate its preference.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose |
8.61; 9.02 | 0.098 |
| SECONDARY Glucose Profiles Per Day |
3.18; 3.63 | 0.004 sig |
| SECONDARY Insulin Delivery System Rating |
82.9; 54.9 | <0.001 sig |
| SECONDARY Self-reported Hypoglycemic Episodes |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes mellitus on intensive insulin therapy
Exclusion Criteria
- Insulin pump therapy
- Current use of NPH or regular insulin
- Severe hypoglycemic episodes in prior 6 months
- Unstable cardiac disease, hepatic, or renal function
Data sourced from ClinicalTrials.gov (NCT01073566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.