Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes

An Assessment of the Impact of an App Based Diabetes Training Program in Conjunction With the Use of BD Nano 2nd Gen 4mm Pen Needle on Diabetes Self-efficacy in People With Type 2 Diabetes

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04090242

Enrollment

Registered

2019-09-16

Start date

2019-09-06

Completion date

2020-06-12

Last updated

2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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.

Detailed description

At Visit 1 (Day -14) site staff will screen and enroll qualified subjects, provide a BGM (Accu-Chek Guide) and attach a blinded flash glucose sensor (Libre Freestyle) to the back of the arm. Subjects will complete any applicable baseline Patient Reported Outcomes (PRO) questionnaires and be sent home with no changes to their current therapy. While at home Subjects will be asked to test blood glucoses using the provided BGM and continue their usual insulin dosing before returning to clinic for Visit 2. Visit 2 will consist of randomization (Interventional Group or Control Group). The control group will be continued on their current pen needle and receive standard visit education as needed. The intervention group will be trained on the use of the DC App and be switched to BD Nano 2nd Gen pen needle. During weeks 3 through 8, subjects in both groups will continue their usual insulin routine, with the control group adhering to their usual practice of managing their diabetes and the intervention group utilizing the DC app for relevant educational content and tips plus using the BD Nano 2nd Gen for all insulin injections. During Visit 3 subjects will get a 2nd fGM sensor placed and be instructed to continue their insulin routine for the final 2 weeks. Visit 4 is the last visit where subjects will have their fGM removed, return the BGM, complete applicable PRO surveys, an injection technique questionnaire and be discharged.

Interventions

DEVICEBD 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 22 years of age minimum 2. Adult subjects with type 2 diabetes mellitus on Multiple daily injections (MDI) and giving themselves at least 2 injections of insulin / day using a pen injector. This may include at minimum i. giving 1 basal injection and at least 1 meal time injection or ii. giving at least 2 daily injections of mixed insulins or iii. giving 2 meal time injections iv. two injections of basal insulin per day will not be considered MDI for this study v. additional OAD/non-insulin injectable therapy is acceptable 3. Must currently be on MDI insulin therapy for at least 6 months prior to enrollment and, in the opinion of the investigator, would benefit from dose optimization. 4. Willing to use the BD provided BGM for the study duration. 5. Hemoglobin A1C of 8.0 - 11% at screening (tested at enrollment unless Subject has a documented HbA1c value on file at the site that was drawn within 3 months of enrollment date). 6. In stable health status with no acute or significant illness, based on the opinion of the investigator. 7. Able to read, write and follow instructions in English (translations will not be provided). 8. Currently using a smartphone and able to understand the use of mobile apps. 9. Able and willing to provide informed consent. 10. Able and willing to follow study procedures.

Exclusion criteria

* Subjects with any one of the following characteristics will be excluded from participation: 1. Pregnant or breast feeding- self reported. 2. Subject on basal-only 3. Uncontrolled comorbidities or acute illness 4. Currently using Nano 2nd Gen pen needles 5. Use of a smartphone with iOS 10.0 or lower or with Android OS 5.0 Lollipop or lower 6. Use of CGM or fGM less than 6 months and not proficient in its use, however this may be left up to the investigators discretion. i. Subjects may continue to wear their own CGM/fGM during their participation in this study if they adhere to the testing of blood glucose using the site provided BGM. 7. Subjects not on stable doses of concomitant non-insulin diabetes medications. Stable is defined as not requiring new non-insulin diabetes medications or any changes in dosing of current non-insulin diabetes medication during study participation (10 weeks) unless warranted by investigator for the safety of the subject. 8. Actively using one of the following diabetes management apps deemed similar and not willing to stop using it during participation on the study (exclusionary apps; Onedrop, Welldoc (Bluestar), Dario, Sugar Sense Glucose, Buddy, mySugr, Omada, Livongo, Accu-Check Connect, SugarIQ). 9. Known sensitivity to adhesives. 10. Currently using the DC app. 11. Employed by, or currently serving as a contractor or consultant to BD or study site 12. Any other condition the investigator deems to pose a risk to the Subject in the study

Design outcomes

Primary

Measure	Time frame	Description
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study	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.

Secondary

Measure	Time frame	Description
Change in 24 Hour Average Blood Glucose From Baseline to End of Study	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.
Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study	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.
Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study	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.
Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study	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.
Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study	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.
Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study	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.
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	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.
Patient Satisfaction at Study End	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.
Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study	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.
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study	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.
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study	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.

Other

Measure	Time frame	Description
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End	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.
Number of Hours of Patient Engagement With App	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	28
Standard Care Standard of Care/Subject is to continue on their current diabetes management regime	30
Total	58

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	App Plus Nano	Standard Care	Total
Age, Continuous	57.0 years STANDARD_DEVIATION 9.8	59.4 years STANDARD_DEVIATION 10.8	58.3 years STANDARD_DEVIATION 10.3
Current Use of Diabetes App No	26 Participants	29 Participants	55 Participants
Current Use of Diabetes App Yes	2 Participants	1 Participants	3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	4 Participants	11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants	26 Participants	47 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	6 Participants	6 Participants	12 Participants
Race/Ethnicity, Customized Black or African American	3 Participants	5 Participants	8 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Other	2 Participants	2 Participants	4 Participants
Race/Ethnicity, Customized White	17 Participants	16 Participants	33 Participants
Region of Enrollment United States	28 participants	30 participants	58 participants
Sex: Female, Male Female	19 Participants	12 Participants	31 Participants
Sex: Female, Male Male	9 Participants	18 Participants	27 Participants
Use of Continuous Blood Glucose Monitoring System No	16 Participants	19 Participants	35 Participants
Use of Continuous Blood Glucose Monitoring System Yes	12 Participants	11 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 30
other Total, other adverse events	2 / 27	3 / 30
serious Total, serious adverse events	0 / 27	1 / 30

Outcome results

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.

Time frame: Baseline (Day -14) and Study End (Day 56)

Arm	Measure	Group	Value (MEAN)	Dispersion
App Plus Nano	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
App Plus Nano	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
Standard Care	Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study	Baseline	4.09 Scores on scale	Standard Deviation 0.66
Standard Care	Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study	End of Study	4.26 Scores on scale	Standard Deviation 0.52

Comparison: 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.p-value: 0.39295% CI: [-0.53, 0.21]Mixed Models Analysis

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.

Time frame: Baseline (Day -14) to Study End (Day 56)

Arm	Measure	Group	Value (MEAN)	Dispersion
App Plus Nano	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
App Plus Nano	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
App Plus Nano	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
App Plus Nano	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 1.5
App Plus Nano	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
App Plus Nano	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
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	Medication Taking Subscale (Baseline)	10.50 score on a scale	Standard Deviation 2.54
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	ARMSD Total Score (Baseline)	16.57 score on a scale	Standard Deviation 4.08
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	Refill Subscale (End of Study)	5.30 score on a scale	Standard Deviation 1.37
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	ARMSD Total Score (End of Study)	15.43 score on a scale	Standard Deviation 3.07
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	Medication Taking Subscale (End of Study)	10.13 score on a scale	Standard Deviation 2.42
Standard Care	Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End	Refill Subscale (Baseline)	6.07 score on a scale	Standard Deviation 2.07

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.