Diabetes Mellitus, Type 2NCT04090242
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
A study testing BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle in people with Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Sep 2019to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age minimum
- 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
- 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.
- Willing to use the BD provided BGM for the study duration.
- 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).
- In stable health status with no acute or significant illness, based on the opinion of the investigator.
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- Able to read, write and follow instructions in English (translations will not be provided).
- Currently using a smartphone and able to understand the use of mobile apps.
- Able and willing to provide informed consent.
- Able and willing to follow study procedures.
Who cannot join
- Subjects with any one of the following characteristics will be excluded from participation:
- Pregnant or breast feeding- self reported.
- Subject on basal-only
- Uncontrolled comorbidities or acute illness
- Currently using Nano 2nd Gen pen needles
- Use of a smartphone with iOS 10.0 or lower or with Android OS 5.0 "Lollipop" or lower
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- 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.
- 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.
- 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.
- 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).
- Known sensitivity to adhesives.
- Currently using the DC app.
- Employed by, or currently serving as a contractor or consultant to BD or study site
- Any other condition the investigator deems to pose a risk to the Subject in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Diabetes and Endocrinology
Austin, Texas, 78749
East West Medical Research Institute
Honolulu, Hawaii, 96814
Mills Pennisula Medical Center-Diabetes Research Institute
San Mateo, California, 94401
Metabolic Research Institute
West Palm Beach, Florida, 33401
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen NeedleDevice
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 group | Role | What they receive |
|---|---|---|
| App plus Nano | Active comparator | Use of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin Receives: Device: BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle |
| Standard Care | No intervention | Standard of Care/Subject is to continue on their current diabetes management regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day -14) and Study End (Day 56)
Secondary outcomes (11)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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.
Measured: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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.
Measured: Baseline (Day -14) to Study End (Day 56)
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.
Measured: Baseline (Day -14) and Study End (Day 56)
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.
Measured: Baseline (Day -14) to Study End (Day 56)
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.
Measured: Administered to participants in the Intervention group only at end of study (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start6 Sep 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Why it stopped: Enrollment halted prematurely due to the Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Mahoney, PhD, Study director, Becton DickinsonDavid Klonoff, M.D, FACP, Principal investigator, Diabetes Research Institute, Mills-Peninsula Medical Center, California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090242
- Sponsor's protocol ID
- DBC-19BRGHT02
- Status last verified
- Jun 2021
- First submitted
- 28 Aug 2019
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04090242
- Acronym / sponsor ID
- DBC-19BRGHT02
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment halted prematurely due to the Covid-19 pandemic
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App plus Nano | Active comparator | Device: BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen NeedleUse of BD Diabetes Care Application for Mobile devices PLUS the use of BD Nano 2nd Gen Pen Needle for delivery of insulin |
| Standard Care | No intervention | –Standard of Care/Subject is to continue on their current diabetes management regime |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 22 years of age minimum
- 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
- 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.
- Willing to use the BD provided BGM for the study duration.
- 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).
Key exclusion criteria (14 listed)
- Subjects with any one of the following characteristics will be excluded from participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen NeedleSubjects 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. | Device | App plus Nano |
Primary outcome
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study
Time frame: 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.
11 secondary outcomes
Change in 24 Hour Average Blood Glucose From Baseline to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study
Time frame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Time frame: Baseline (Day -14) to Study End (Day 56)
Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Time frame: Baseline (Day -14) and Study End (Day 56)
Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Time frame: Baseline (Day -14) to Study End (Day 56)
Patient Satisfaction at Study End
Time frame: Administered to participants in the Intervention group only at end of study (Day 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Mahoney, PhD study director
Becton Dickinson
David Klonoff, M.D, FACP principal investigator
Diabetes Research Institute, Mills-Peninsula Medical Center, California
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle in people with Diabetes Mellitus, Type 2, run by Becton, Dickinson and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study (time frame: Baseline (Day -14) and Study End (Day 56)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021; AzTrials last refreshed its copy on 26 Oct 2026.