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

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ClinicalTrials.gov Identifier: NCT04090242
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Device: 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.

No Intervention: Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime



Primary Outcome Measures :
  1. Change in Attitudes Toward Diabetes - Diabetes Empowerment Scale (DES) [ 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.


Secondary Outcome Measures :
  1. Change in 24 hour average blood glucose [ Time Frame: 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.

  2. Time in range [ Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) ]
    Data collected by the flash glucose monitor will also be used to calculate percent of time spent <54 mg/dL, <70 mg/dL, 70-180 mg/dL, and >180mg/dL to compare differences between groups at baseline and study end.

  3. Change in Mean Amplitude of Glycemic Excursion (MAGE) [ Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) ]
    • Flash glucose monitoring data will be used to measure glycemic variability changes at baseline and study end between groups.
    • Within group comparisons will be conducted at baseline and study end for 24 hour average blood glucose, time in range, MAGE and frequency of hypoglycemia.

  4. Change in Diabetes Distress Screening Scale - 17 (DDS17) [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]
    Description: A standardized questionnaire including 17, 6-point Likert Scale questions where 1 indicates no problem and 6 indicates a very serious problem. The DDS17 yields a total score plus 4 subscale scores, each addressing a different kinds of distress. The total score is calculated by averaging all item scores. A mean item score of ≥2 is considered moderate distress or greater. The emotion burden subscale score is calculated by averaging 5 items. A mean item score >2 indicates moderate distress or greater. The physician distress subscale score is calculated by averaging 4 items. A mean item score >2 indicates moderate distress or greater. The regimen distress subscale score is calculated by averaging 5 items. A mean item score >2 indicates moderate distress or greater. The interpersonal distress subscale score is calculated by averaging 3 items. A mean item score of ≥2 indicates moderate distress or greater.

  5. Change in Insulin Delivery System Rating Questionnaire - IDSRQ [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]
    A standardized questionnaire including several questions with ordinal response scales from 1 to 4 or 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.

  6. Change in Adherence to Refills and Medications Scale for Diabetes - ARMS-D [ Time Frame: 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.

  7. Patient Satisfaction [ Time Frame: 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.


Other Outcome Measures:
  1. Frequency of hypoglycemia [ Time Frame: 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.

  2. Change in Patient Engagement [ Time Frame: Baseline (Day 1) to Study End (Day 56) ]

    Patient Engagement: Engagement with The DC App will be measured by app collected usage analytics and will include assessments of time spent within app, frequency of opening the app, types of articles accessed, types of data logged, and frequency of article access or data logging.

    • Within group comparisons of highly engaged app users compared to minimally engaged users will be performed for all outcomes listed in primary and secondary endpoint sections above.

  3. Injection Technique Questionnaire: [ Time Frame: Study end (Day 56) ]
    A questionnaire including 10 multiple choice questions. Each individual item is scored with either a 0 or 3. The total score ranges from 0 to 30 by summing all item scores together where a lower score indicates better injection technique.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090242


Contacts
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Contact: Diane Sutter 19199497034 Diane_Sutter@bd.com
Contact: Edward Mahoney, Ph.D 978-901-7248 Edward.Mahoney@bd.com

Locations
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United States, California
Mills Pennisula Medical Center-Diabetes Research Institute Not yet recruiting
San Mateo, California, United States, 94401
Contact: Irina Nayberg    650-696-4261    nayberi@sutterhealth.org   
Principal Investigator: David Klonoff, MD         
United States, Hawaii
East West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
Contact: Ron Ruhaak    808-440-4426    ron@eastwestresearch.com   
Principal Investigator: David Fitz-Patrick, MD         
United States, Texas
Texas Diabetes and Endocrinology Recruiting
Austin, Texas, United States, 78749
Contact: Alison Cooper    512-334-3505    acooper@texasdiabetes.com   
Principal Investigator: Lindsey Harrison, MD         
Sponsors and Collaborators
Becton, Dickinson and Company

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Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT04090242     History of Changes
Other Study ID Numbers: DBC-19BRGHT02
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases