Trial Outcomes & Findings for Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes (NCT NCT04090242)
NCT ID: NCT04090242
Last Updated: 2021-07-08
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline (Day -14) and Study End (Day 56)
Results posted on
2021-07-08
Participant Flow
Participant milestones
| Measure |
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.
|
Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
Baseline characteristics by cohort
| Measure |
App Plus Nano
n=28 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Current Use of Diabetes App
No
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Current Use of Diabetes App
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Use of Continuous Blood Glucose Monitoring System
No
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Use of Continuous Blood Glucose Monitoring System
Yes
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -14) and Study End (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study
Baseline
|
4.16 Scores on scale
Standard Deviation 0.55
|
4.09 Scores on scale
Standard Deviation 0.66
|
|
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study
End of Study
|
4.17 Scores on scale
Standard Deviation 0.84
|
4.26 Scores on scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Change in 24 Hour Average Blood Glucose From Baseline to End of Study
Baseline
|
187.0 mg/dl
Standard Deviation 39.7
|
161.8 mg/dl
Standard Deviation 37.9
|
|
Change in 24 Hour Average Blood Glucose From Baseline to End of Study
End of study
|
184.9 mg/dl
Standard Deviation 55.7
|
173.1 mg/dl
Standard Deviation 45.3
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study
Baseline
|
0.73 Percent of time
Standard Deviation 1.11
|
2.68 Percent of time
Standard Deviation 5.14
|
|
Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study
End of study
|
0.83 Percent of time
Standard Deviation 1.05
|
1.07 Percent of time
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study
Baseline
|
2.54 Percent of time
Standard Deviation 3.18
|
6.37 Percent of time
Standard Deviation 9.31
|
|
Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study
End of study
|
3.34 Percent of time
Standard Deviation 3.46
|
3.46 Percent of time
Standard Deviation 3.46
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study
Baseline
|
49.35 Percent of time
Standard Deviation 18.93
|
58.75 Percent of time
Standard Deviation 18.58
|
|
Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study
End of study
|
51.85 Percent of time
Standard Deviation 23.17
|
57.19 Percent of time
Standard Deviation 23.43
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study
Baseline
|
48.11 Percent of time
Standard Deviation 20.20
|
34.88 Percent of time
Standard Deviation 22.0
|
|
Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study
End of study
|
44.82 Percent of time
Standard Deviation 24.79
|
39.35 Percent of time
Standard Deviation 24.82
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study
Baseline
|
18.92 Percent of time
Standard Deviation 17.67
|
11.29 Percent of time
Standard Deviation 11.11
|
|
Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study
End of study
|
19.29 Percent of time
Standard Deviation 21.09
|
15.54 Percent of time
Standard Deviation 18.49
|
SECONDARY outcome
Timeframe: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study
Baseline
|
133.64 mg/dl
Standard Deviation 26.38
|
121.68 mg/dl
Standard Deviation 19.99
|
|
Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study
End of study
|
127.57 mg/dl
Standard Deviation 25.04
|
124.16 mg/dl
Standard Deviation 19.12
|
SECONDARY outcome
Timeframe: Baseline (Day -14) to Study End (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Interpersonal Distress Subscale (End of Study)
|
1.69 Score on a scale
Standard Deviation 1.05
|
2.24 Score on a scale
Standard Deviation 1.35
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Total Score (Baseline)
|
1.81 Score on a scale
Standard Deviation 0.66
|
2.03 Score on a scale
Standard Deviation 0.92
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Total Score (End of Study)
|
1.83 Score on a scale
Standard Deviation 0.61
|
2.10 Score on a scale
Standard Deviation 1.01
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Emotional Burden Subscale (Baseline)
|
2.19 Score on a scale
Standard Deviation 1.22
|
2.19 Score on a scale
Standard Deviation 1.08
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Emotional Burden Subscale (End of Study)
|
2.21 Score on a scale
Standard Deviation 1.06
|
2.17 Score on a scale
Standard Deviation 1.09
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Physician Distress Subscale (Baseline)
|
1.01 Score on a scale
Standard Deviation 0.05
|
1.48 Score on a scale
Standard Deviation 1.10
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Physician Distress Subscale (End of Study)
|
1.05 Score on a scale
Standard Deviation 0.20
|
1.48 Score on a scale
Standard Deviation 1.14
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Regimen Distress Subscale (Baseline)
|
2.23 Score on a scale
Standard Deviation 0.86
|
2.39 Score on a scale
Standard Deviation 1.10
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Regimen Distress Subscale (End of Study)
|
2.16 Score on a scale
Standard Deviation 0.73
|
2.43 Score on a scale
Standard Deviation 1.07
|
|
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Interpersonal Distress Subscale (Baseline)
|
1.57 Score on a scale
Standard Deviation 0.90
|
1.89 Score on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline (Day -14) and Study End (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Satisfaction Subscale (Baseline)
|
67.83 Score on a scale
Standard Deviation 2.45
|
66.45 Score on a scale
Standard Deviation 23.46
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Satisfaction Subscale (End of Study)
|
72.76 Score on a scale
Standard Deviation 22.20
|
69.72 Score on a scale
Standard Deviation 18.89
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Interference Subscale (Baseline)
|
25.31 Score on a scale
Standard Deviation 15.49
|
17.95 Score on a scale
Standard Deviation 20.57
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Interference Subscale (End of Study)
|
27.01 Score on a scale
Standard Deviation 19.85
|
25.28 Score on a scale
Standard Deviation 21.81
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Clinical Efficacy Subscale (Baseline)
|
58.02 Score on a scale
Standard Deviation 21.34
|
53.24 Score on a scale
Standard Deviation 21.48
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Clinical Efficacy Subscale (End of Study)
|
58.85 Score on a scale
Standard Deviation 22.03
|
53.70 Score on a scale
Standard Deviation 19.54
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Diabetes-Related Worry Subscale (Baseline)
|
41.98 Score on a scale
Standard Deviation 22.26
|
40.00 Score on a scale
Standard Deviation 18.30
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Diabetes-Related Worry Subscale (End of Study)
|
42.28 Score on a scale
Standard Deviation 23.48
|
39.31 Score on a scale
Standard Deviation 19.26
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Social Burden Subscale (Baseline)
|
35.19 Score on a scale
Standard Deviation 19.83
|
37.58 Score on a scale
Standard Deviation 16.36
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Social Burden Subscale (End of Study)
|
32.80 Score on a scale
Standard Deviation 16.28
|
35.12 Score on a scale
Standard Deviation 16.78
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Well-Being Subscale (Baseline)
|
42.28 Score on a scale
Standard Deviation 12.01
|
43.94 Score on a scale
Standard Deviation 13.24
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Well-Being Subscale (End of Study)
|
47.41 Score on a scale
Standard Deviation 13.49
|
44.33 Score on a scale
Standard Deviation 13.65
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Treatment Preference Subscale (End of Study)
|
63.35 Score on a scale
Standard Deviation 13.66
|
59.31 Score on a scale
Standard Deviation 14.46
|
|
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Treatment Preference Subscale (Baseline)
|
64.20 Score on a scale
Standard Deviation 14.74
|
57.08 Score on a scale
Standard Deviation 15.29
|
SECONDARY outcome
Timeframe: Baseline (Day -14) to Study End (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Refill Subscale (Baseline)
|
5.30 score on a scale
Standard Deviation 1.51
|
6.07 score on a scale
Standard Deviation 2.07
|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
ARMSD Total Score (Baseline)
|
15.67 score on a scale
Standard Deviation 3.46
|
16.57 score on a scale
Standard Deviation 4.08
|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
ARMSD Total Score (End of Study)
|
16.07 score on a scale
Standard Deviation 3.65
|
15.43 score on a scale
Standard Deviation 3.07
|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Refill Subscale (End of Study)
|
5.37 score on a scale
Standard Deviation 1.50
|
5.30 score on a scale
Standard Deviation 1.37
|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Medication Taking Subscale (Baseline)
|
10.37 score on a scale
Standard Deviation 2.79
|
10.50 score on a scale
Standard Deviation 2.54
|
|
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Medication Taking Subscale (End of Study)
|
10.70 score on a scale
Standard Deviation 2.71
|
10.13 score on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Administered to participants in the Intervention group only at end of study (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Patient Satisfaction at Study End
Pen Needle Subscale
|
25.30 score on a scale
Standard Deviation 6.35
|
—
|
|
Patient Satisfaction at Study End
Patient Satisfaction Subscale
|
63.52 score on a scale
Standard Deviation 15.93
|
—
|
|
Patient Satisfaction at Study End
Mobile App Subscale
|
21.96 score on a scale
Standard Deviation 6.66
|
—
|
|
Patient Satisfaction at Study End
System Subscale
|
16.26 score on a scale
Standard Deviation 4.38
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day -14) to Study End (Day 56)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.
Outcome measures
| Measure |
App Plus Nano
n=28 Participants
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.
|
Standard Care
n=30 Participants
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
% time <54 mg/dL (Baseline)
|
0.7 Hypoglycemic events
Standard Deviation 1.1
|
2.7 Hypoglycemic events
Standard Deviation 5.1
|
|
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
% time <54 mg/dL (Study End)
|
0.8 Hypoglycemic events
Standard Deviation 1.1
|
1.1 Hypoglycemic events
Standard Deviation 1.3
|
|
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
% Time < 70 mg/dl (Baseline)
|
2.5 Hypoglycemic events
Standard Deviation 3.2
|
6.4 Hypoglycemic events
Standard Deviation 9.3
|
|
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
% Time < 70 mg/dl (End of Study)
|
3.3 Hypoglycemic events
Standard Deviation 3.5
|
3.5 Hypoglycemic events
Standard Deviation 3.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1) to Study End (Day 56)Patient Engagement: Engagement with The DC App will be measured by app collected usage analytics and main assessment was time spent within app.
Outcome measures
| Measure |
App Plus Nano
n=27 Participants
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.
|
Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Number of Hours of Patient Engagement With App
|
7.2 Hours
Standard Deviation 20.1
|
—
|
Adverse Events
App Plus Nano
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Care
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
App Plus Nano
n=27 participants at risk
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.
|
Standard Care
n=30 participants at risk
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/27 • Adverse events reported between week 1 and week 10 of the study.
|
3.3%
1/30 • Number of events 1 • Adverse events reported between week 1 and week 10 of the study.
|
Other adverse events
| Measure |
App Plus Nano
n=27 participants at risk
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.
|
Standard Care
n=30 participants at risk
Standard of Care/Subject is to continue on their current diabetes management regime
|
|---|---|---|
|
Infections and infestations
Upper respiratory Tract Infection
|
7.4%
2/27 • Number of events 2 • Adverse events reported between week 1 and week 10 of the study.
|
3.3%
1/30 • Number of events 1 • Adverse events reported between week 1 and week 10 of the study.
|
|
General disorders
Common Cold
|
0.00%
0/27 • Adverse events reported between week 1 and week 10 of the study.
|
6.7%
2/30 • Number of events 2 • Adverse events reported between week 1 and week 10 of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER