Clinical trial NCT04090242: Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 58
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study
timeFrame: Baseline (Day -14) and Study End (Day 56)
Secondary outcomes:
measure: Change in 24 Hour Average Blood Glucose From Baseline to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
measure: Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
measure: Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
measure: Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
measure: Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
measure: Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
measure: Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study
timeFrame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
measure: Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
timeFrame: Baseline (Day -14) to Study End (Day 56)
measure: Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
timeFrame: Baseline (Day -14) and Study End (Day 56)
measure: Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
timeFrame: Baseline (Day -14) to Study End (Day 56)
measure: Patient Satisfaction at Study End
timeFrame: Administered to participants in the Intervention group only at end of study (Day 56)
Other outcomes:
measure: Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
timeFrame: Baseline (Day -14) to Study End (Day 56)
measure: Number of Hours of Patient Engagement With App
timeFrame: Baseline (Day 1) to Study End (Day 56)
Locations:
city: San Mateo
country: United States
facility: Mills Pennisula Medical Center-Diabetes Research Institute
state: California
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Honolulu
country: United States
facility: East West Medical Research Institute
state: Hawaii
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
Study officials:
affiliation: Becton Dickinson
name: Edward Mahoney, PhD
role: STUDY_DIRECTOR
affiliation: Diabetes Research Institute, Mills-Peninsula Medical Center, California
name: David Klonoff, M.D, FACP
role: PRINCIPAL_INVESTIGATOR
References: