| Primary | Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study | A standardized questionnaire including 8 questions with response categories of 'strongly disagree', 'somewhat disagree', 'neutral', 'somewhat agree', and 'strongly agree'. An overall score for the DES is calculated by summing all of the item scores and dividing by 8 for a possible score range of 1-5 where a higher score indicates a higher level of empowerment. | | Posted | | Mean | Standard Deviation | Scores on scale | | Baseline (Day -14) and Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG0004.16± 0.55
- OG0014.09± 0.66
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| | End of Study | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had >80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions. | Mixed Models Analysis | | 0.392 | The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study. | Mean Difference (Final Values) | -0.16 | | | 2-Sided | 95 | -0.53 | 0.21 | | | | |
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| Secondary | Change in 24 Hour Average Blood Glucose From Baseline to End of Study | Freestyle Libre Pro blinded flash glucose monitoring will be used to assess change in average 24 hour blood glucose between groups Subjects will wear Libre sensors on the backs of their arm for the 2 weeks at the beginning of the study and 2 weeks at the end of the study. | | Posted | | Mean | Standard Deviation | mg/dl | | Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study | Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end. For example, Time below 54 mg/dl is calculated in the following manner: Number of all glucose data points below 54 mg/dl / total number of glucose data points X 100. Since data points are all 5 minutes apart, this calculation provides the percentage of time in that range. | | Posted | | Mean | Standard Deviation | Percent of time | | Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study | Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end. | | Posted | | Mean | Standard Deviation | Percent of time | | Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study | Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end. | | Posted | | Mean | Standard Deviation | Percent of time | | Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study | Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end. | | Posted | | Mean | Standard Deviation | Percent of time | | Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study | Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end. | | Posted | | Mean | Standard Deviation | Percent of time | | Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study | Flash glucose monitoring data were used to measure glycemic variability changes at baseline and study end between groups. Measuring glycemic variability helps determine how much glucose levels change over the course of a day or between days. | | Posted | | Mean | Standard Deviation | mg/dl | | Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study | A standardized questionnaire including 17, 6-point Likert Scale questions where 1 indicates "Not a problem", 2 indicates "A slight problem", 3 means "A moderate problem", 4 indicates a "Somewhat serious problem", 5 indicates "A serious problem", and 6 means "A very serious problem". Using this scale, a Total Score, Emotional Burden Score, Physician Score, Regimen Distress Score, and Interpersonal Score were calculated. | | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline (Day -14) to Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study | A standardized questionnaire including several questions with ordinal response scales from 1 to 4 and 1 to 5. The IDSRQ has seven sub-scales (satisfaction, interference of treatment with daily activities, diabetes-related worries, clinical efficacy, psychological well-being, social burden, and treatment preference). Each sub-scale is calculated as a mean of their corresponding items with scores ranging from 0-100. Higher scores represent higher levels of satisfaction, perceived clinical efficacy, and psychological well-being, interference with daily activities, diabetes-related worries, and social burden. | | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline (Day -14) and Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End | A standardized questionnaire including 11 multiple choice questions. The ARMS-D yields a total score plus two sub-scale scores (refill sub-scale and medication taking sub-scale. Items 1-10 are scored as follows: 1= none of the time, 2 = some of the time, 3 = most of the time, and 4 = all of the time. Item 11 is reversed scored. The ARMS-D total is a sum of all items for a possible score ranging from 11-44. The ARMS-D refill sub-scale is a sum of 4 items for a possible score ranging from 4-16. The ARMS-D medication taking sub-scale is a sum of 7 items for a possible score ranging from 7-28. Lower scores indicate better adherence. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day -14) to Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Secondary | Patient Satisfaction at Study End | A questionnaire including 16, 5-point Likert Scale questions where 1 indicates strongly disagree and 5 indicates strongly agree. This questionnaire yields a total satisfaction score plus three sub-scale scores (mobile app satisfaction, pen needle satisfaction, and injection management system satisfaction). The total score ranges from 16-80. The mobile app and pen needle satisfaction sub-scale score range from 6-30 and is a sum of all items in the associated sub-scale. The management system sub-scale score ranges from 4-20 and is a sum of all items in the sub-scale. Higher scores indicate higher satisfaction. | | Posted | | Mean | Standard Deviation | score on a scale | | Administered to participants in the Intervention group only at end of study (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin. |
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| Other Pre-specified | Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End | Frequency of hypoglycemia: The number of hypoglycemic events (<70mg/dL and <54mg/dL) as measured by blood glucose monitor (BGM) will be collected to determine frequency of hypoglycemia in each group. | | Posted | | Mean | Standard Deviation | Hypoglycemic events | | Baseline (Day -14) to Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle: Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team. | | OG001 | Standard Care | Standard of Care/Subject is to continue on their current diabetes management regime |
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| Other Pre-specified | Number of Hours of Patient Engagement With App | Patient Engagement: Engagement with The DC App will be measured by app collected usage analytics and main assessment was time spent within app. | | Posted | | Mean | Standard Deviation | Hours | | Baseline (Day 1) to Study End (Day 56) | | | | ID | Title | Description |
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| OG000 | App Plus Nano | Use of BD Diabetes care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin. |
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