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

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT04090242

Run by

Becton, Dickinson and Company

People needed

58

Starts

2019-09-06

Expected to finish

2020-06-12

Last updated by the study team

2021-07-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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