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

NCT04090242 | Terminated Results FDA Device

• 1 other identifier: DBC-19BRGHT02
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day -14) and Study End (Day 56)

Secondary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End

  Baseline (Day -14) to Study End (Day 56)

• Number of Hours of Patient Engagement With App

  Baseline (Day 1) to Study End (Day 56)

Study Arms (2)

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

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

Interventions

BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle DEVICE

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.

App plus Nano

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.
• 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.
• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (4)

Mills Pennisula Medical Center-Diabetes Research Institute

San Mateo, California, 94401, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78749, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Edward Mahoney
• Organization: Becton Dickinson

Edward.Mahoney@bd.com

978-901-7248

Study Officials

• Edward Mahoney, PhD

  Becton Dickinson

  STUDY DIRECTOR

• David Klonoff, M.D, FACP

  Diabetes Research Institute, Mills-Peninsula Medical Center, California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 16, 2019
• Study Start: September 6, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)