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

NCT ID: NCT04090242

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-06
• Study Completion Date: 2020-06-12

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Standard Care

Standard of Care/Subject is to continue on their current diabetes management regime

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Mahoney, PhD

Role: STUDY_DIRECTOR

Becton Dickinson

David Klonoff, M.D, FACP

Role: PRINCIPAL_INVESTIGATOR

Diabetes Research Institute, Mills-Peninsula Medical Center, California

Locations

Mills Pennisula Medical Center-Diabetes Research Institute

San Mateo, California, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

East West Medical Research Institute

Honolulu, Hawaii, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DBC-19BRGHT02

Identifier Type: -

Identifier Source: org_study_id