Trial Outcomes & Findings for Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections (NCT NCT01073566)
NCT ID: NCT01073566
Last Updated: 2025-02-04
Results Overview
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Finesse Then Usual Injection Device
Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
|
Usual Injection Device Then Finesse
Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
|
|---|---|---|
|
Period 1 (6 Weeks)
STARTED
|
19
|
19
|
|
Period 1 (6 Weeks)
COMPLETED
|
19
|
19
|
|
Period 1 (6 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (6 Weeks)
STARTED
|
19
|
19
|
|
Period 2 (6 Weeks)
COMPLETED
|
18
|
19
|
|
Period 2 (6 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Finesse Then Usual Injection Device
Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
|
Usual Injection Device Then Finesse
Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
|
|---|---|---|
|
Period 2 (6 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Feasibility Study of Finesse for Bolus Prandial Insulin Dosing Compared to Multiple Daily Injections
Baseline characteristics by cohort
| Measure |
Finesse Then Usual Injection Device
n=19 Participants
Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
|
Usual Injection Device Then Finesse
n=19 Participants
Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Intent to treat
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Outcome measures
| Measure |
Finesse
n=38 Participants
Bolus Patch
|
Usual Injection Device
n=38 Participants
Pen/Syringe
|
|---|---|---|
|
Mean Daily Blood Glucose
|
8.61 mmol/L
Standard Error 0.28
|
9.02 mmol/L
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intent to Treat
Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Outcome measures
| Measure |
Finesse
n=38 Participants
Bolus Patch
|
Usual Injection Device
n=38 Participants
Pen/Syringe
|
|---|---|---|
|
Glucose Profiles Per Day
|
3.18 mmol/L
Standard Error 0.18
|
3.63 mmol/L
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Per Protocol
Subject satisfaction with insulin delivery was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.
Outcome measures
| Measure |
Finesse
n=38 Participants
Bolus Patch
|
Usual Injection Device
n=37 Participants
Pen/Syringe
|
|---|---|---|
|
Insulin Delivery System Rating
|
82.9 units on a scale
Standard Deviation 14.5
|
54.9 units on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Intent to treat
Severe hypoglycemia is defined as episodes in which the patient experienced coma, seizure, or suspected seizure or impairment sufficient to require the assistance of another person and either the blood glucose level is measured and found to be \<50 mg/dl or the clinical manifestations were reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose.
Outcome measures
| Measure |
Finesse
n=38 Participants
Bolus Patch
|
Usual Injection Device
n=38 Participants
Pen/Syringe
|
|---|---|---|
|
Self-reported Hypoglycemic Episodes
|
0 episodes
|
0 episodes
|
Adverse Events
Finesse
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Usual Injection Device
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Finesse
n=38 participants at risk
Bolus Patch
|
Usual Injection Device
n=38 participants at risk
Pen/Syringe
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
2.6%
1/38 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.00%
0/38
|
2.6%
1/38 • Number of events 1
|
Other adverse events
| Measure |
Finesse
n=38 participants at risk
Bolus Patch
|
Usual Injection Device
n=38 participants at risk
Pen/Syringe
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Gastrointestinal disorders
Tooth ache
|
0.00%
0/38
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/38
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Medical device site reaction
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Acute pyelonephritis
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Flu
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/38
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/38
|
10.8%
4/37 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/38
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.6%
1/38 • Number of events 1
|
0.00%
0/37
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place