Status:
TERMINATED
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
22+ years
Phase:
NA
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 ei...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04090242
Start Date
September 6 2019
End Date
June 12 2020
Last Update
July 8 2021
Active Locations (4)
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1
Mills Pennisula Medical Center-Diabetes Research Institute
San Mateo, California, United States, 94401
2
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
3
East West Medical Research Institute
Honolulu, Hawaii, United States, 96814
4
Texas Diabetes and Endocrinology
Austin, Texas, United States, 78749