Diabetes Mellitus
Conditions
Keywords
Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Insulin, Metabolic Diseases
Brief 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.
Detailed description
The aim of this feasibility study is to compare efficacy, device satisfaction and quality of life (QOL) in people with type 1 or 2 diabetes delivering mealtime insulin using a novel insulin bolus-patch (Finesse™; Calibra Medical, Inc., Redwood City, CA) versus current devices that deliver bolus insulin (pen/syringe). All subjects injected their basal insulin using their current pen/syringe.
Interventions
DEVICEFinesse
Finesse Insulin Delivery Patch
DEVICEPen/Syringe (Usual injection device)
Pen/Syringe
Sponsors
Nancy Bohannon, MD, Med. Corp.
Henry Ford Health System
Northwestern University
University of Texas Southwestern Medical Center
International Diabetes Center at Park Nicollet
Calibra Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Daily Blood Glucose | 6 weeks | Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Profiles Per Day | 6 weeks | Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days |
| Insulin Delivery System Rating | 6 weeks | 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. |
| Self-reported Hypoglycemic Episodes | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| 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 | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (6 Weeks) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Injection Device Then Finesse | Finesse Then Usual Injection Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 15.3 | 49.8 years STANDARD_DEVIATION 15.5 | 47.3 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 38 | 9 / 38 |
| serious Total, serious adverse events | 1 / 38 | 1 / 38 |
Outcome results
Primary
Mean Daily Blood Glucose
Equivalence of Finesse to Usual Injection Device in Mean Daily Blood Glucose
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finesse | Mean Daily Blood Glucose | 8.61 mmol/L | Standard Error 0.28 |
| Usual Injection Device | Mean Daily Blood Glucose | 9.02 mmol/L | Standard Error 0.26 |
Comparison: A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.p-value: 0.09895% CI: [-0.97, 0.16]ANOVA
Secondary
Glucose Profiles Per Day
Standard deviation of 7 daily blood glucose values (3 pre-meal, 3 post-meal, and bedtime) for 3 days
Time frame: 6 weeks
Population: Intent to Treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finesse | Glucose Profiles Per Day | 3.18 mmol/L | Standard Error 0.18 |
| Usual Injection Device | Glucose Profiles Per Day | 3.63 mmol/L | Standard Error 0.17 |
Comparison: This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.p-value: 0.00495% CI: [-0.8, -0.17]ANOVA
Secondary
Insulin Delivery System Rating
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.
Time frame: 6 weeks
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Finesse | Insulin Delivery System Rating | 82.9 units on a scale | Standard Deviation 14.5 |
| Usual Injection Device | Insulin Delivery System Rating | 54.9 units on a scale | Standard Deviation 17.5 |
Comparison: Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.p-value: <0.001McNemar
Secondary
Self-reported Hypoglycemic Episodes
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.
Time frame: 6 weeks
Population: Intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Finesse | Self-reported Hypoglycemic Episodes | 0 episodes |
| Usual Injection Device | Self-reported Hypoglycemic Episodes | 0 episodes |