Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
TerminatedNAResults postedLast updated 8 July 2021
What this trial tests
NA trial testing BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle in Diabetes Mellitus, Type 2 in 58 participants. Terminated before completion.
22 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of StudyPrimary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
4.16
± 0.55
Standard Care
4.09
± 0.66
End of Study
Group
Value
95% CI
App Plus Nano
4.17
± 0.84
Standard Care
4.26
± 0.52
Change in 24 Hour Average Blood Glucose From Baseline to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
187.0
± 39.7
Standard Care
161.8
± 37.9
End of study
Group
Value
95% CI
App Plus Nano
184.9
± 55.7
Standard Care
173.1
± 45.3
Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
0.73
± 1.11
Standard Care
2.68
± 5.14
End of study
Group
Value
95% CI
App Plus Nano
0.83
± 1.05
Standard Care
1.07
± 1.25
Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
2.54
± 3.18
Standard Care
6.37
± 9.31
End of study
Group
Value
95% CI
App Plus Nano
3.34
± 3.46
Standard Care
3.46
± 3.46
Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
49.35
± 18.93
Standard Care
58.75
± 18.58
End of study
Group
Value
95% CI
App Plus Nano
51.85
± 23.17
Standard Care
57.19
± 23.43
Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
48.11
± 20.20
Standard Care
34.88
± 22.0
End of study
Group
Value
95% CI
App Plus Nano
44.82
± 24.79
Standard Care
39.35
± 24.82
Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
18.92
± 17.67
Standard Care
11.29
± 11.11
End of study
Group
Value
95% CI
App Plus Nano
19.29
± 21.09
Standard Care
15.54
± 18.49
Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of StudySecondary· 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.
Baseline
Group
Value
95% CI
App Plus Nano
133.64
± 26.38
Standard Care
121.68
± 19.99
End of study
Group
Value
95% CI
App Plus Nano
127.57
± 25.04
Standard Care
124.16
± 19.12
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of StudySecondary· 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.
Total Score (Baseline)
Group
Value
95% CI
App Plus Nano
1.81
± 0.66
Standard Care
2.03
± 0.92
Total Score (End of Study)
Group
Value
95% CI
App Plus Nano
1.83
± 0.61
Standard Care
2.10
± 1.01
Emotional Burden Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
2.19
± 1.22
Standard Care
2.19
± 1.08
Emotional Burden Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
2.21
± 1.06
Standard Care
2.17
± 1.09
Physician Distress Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
1.01
± 0.05
Standard Care
1.48
± 1.10
Physician Distress Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
1.05
± 0.20
Standard Care
1.48
± 1.14
Regimen Distress Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
2.23
± 0.86
Standard Care
2.39
± 1.10
Regimen Distress Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
2.16
± 0.73
Standard Care
2.43
± 1.07
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of StudySecondary· 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 so
Satisfaction Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
67.83
± 2.45
Standard Care
66.45
± 23.46
Satisfaction Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
72.76
± 22.20
Standard Care
69.72
± 18.89
Interference Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
25.31
± 15.49
Standard Care
17.95
± 20.57
Interference Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
27.01
± 19.85
Standard Care
25.28
± 21.81
Clinical Efficacy Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
58.02
± 21.34
Standard Care
53.24
± 21.48
Clinical Efficacy Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
58.85
± 22.03
Standard Care
53.70
± 19.54
Diabetes-Related Worry Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
41.98
± 22.26
Standard Care
40.00
± 18.30
Diabetes-Related Worry Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
42.28
± 23.48
Standard Care
39.31
± 19.26
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study EndSecondary· 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. Low
ARMSD Total Score (Baseline)
Group
Value
95% CI
App Plus Nano
15.67
± 3.46
Standard Care
16.57
± 4.08
ARMSD Total Score (End of Study)
Group
Value
95% CI
App Plus Nano
16.07
± 3.65
Standard Care
15.43
± 3.07
Refill Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
5.30
± 1.51
Standard Care
6.07
± 2.07
Refill Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
5.37
± 1.50
Standard Care
5.30
± 1.37
Medication Taking Subscale (Baseline)
Group
Value
95% CI
App Plus Nano
10.37
± 2.79
Standard Care
10.50
± 2.54
Medication Taking Subscale (End of Study)
Group
Value
95% CI
App Plus Nano
10.70
± 2.71
Standard Care
10.13
± 2.42
Patient Satisfaction at Study EndSecondary· 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 highe
Patient Satisfaction Subscale
Group
Value
95% CI
App Plus Nano
63.52
± 15.93
Mobile App Subscale
Group
Value
95% CI
App Plus Nano
21.96
± 6.66
Pen Needle Subscale
Group
Value
95% CI
App Plus Nano
25.30
± 6.35
System Subscale
Group
Value
95% CI
App Plus Nano
16.26
± 4.38
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events reported between week 1 and week 10 of the study..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multi-center, open-label, parallel-group, randomized controlled study in subjects with type 2 diabetes using multiple daily injection (MDI) insulin therapy. Subjects will be randomized to either receive the DC App and BD Nano 2nd Gen pen needles (intervention) or continue their standard of care using their current pen needle and diabetes management (control). The study will consist of four visits and two scheduled phone calls across a total of 10 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Other recruiting trials for Diabetes Mellitus, Type 2
Currently open trials in the same condition.
NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2
· Phase 2
· recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part
· recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use
· NA
· recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
· Phase 1
· recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0
· recruiting
Other Becton, Dickinson and Company trials
Trials by the same sponsor.
NCT06632509 — BD SiteRite(TM) 9 Ultrasound System - Clinical Study
· completed
NCT06632496 — BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study
· completed
NCT06604026 — Investigational Study With the BD PosiFlush™ SafeScrub on NADs
· NA
· recruiting
NCT06426121 — Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
· completed
NCT05953363 — Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Becton, Dickinson and Company
Last refreshed: 8 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04090242.