Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04090242|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||September 6, 2019|
|Estimated Primary Completion Date :||June 12, 2020|
|Estimated Study Completion Date :||June 12, 2020|
Active Comparator: 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
Device: 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.
No Intervention: Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
- Change in Attitudes Toward Diabetes - Diabetes Empowerment Scale (DES) [ Time Frame: Baseline (Day -14) and Study End (Day 56) ]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.
- Change in 24 hour average blood glucose [ Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56) ]Freestyle Libre Pro blinded flash glucose monitoring will be used to assess change in average 24 hour blood glucose between groups Subjects will wear Libre sensors on the backs of their arm for the 2 weeks at the beginning of the study and 2 weeks at the end of the study.
- Time in range [ Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) ]Data collected by the flash glucose monitor will also be used to calculate percent of time spent <54 mg/dL, <70 mg/dL, 70-180 mg/dL, and >180mg/dL to compare differences between groups at baseline and study end.
- Change in Mean Amplitude of Glycemic Excursion (MAGE) [ Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56) ]
- Flash glucose monitoring data will be used to measure glycemic variability changes at baseline and study end between groups.
- Within group comparisons will be conducted at baseline and study end for 24 hour average blood glucose, time in range, MAGE and frequency of hypoglycemia.
- Change in Diabetes Distress Screening Scale - 17 (DDS17) [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]Description: A standardized questionnaire including 17, 6-point Likert Scale questions where 1 indicates no problem and 6 indicates a very serious problem. The DDS17 yields a total score plus 4 subscale scores, each addressing a different kinds of distress. The total score is calculated by averaging all item scores. A mean item score of ≥2 is considered moderate distress or greater. The emotion burden subscale score is calculated by averaging 5 items. A mean item score >2 indicates moderate distress or greater. The physician distress subscale score is calculated by averaging 4 items. A mean item score >2 indicates moderate distress or greater. The regimen distress subscale score is calculated by averaging 5 items. A mean item score >2 indicates moderate distress or greater. The interpersonal distress subscale score is calculated by averaging 3 items. A mean item score of ≥2 indicates moderate distress or greater.
- Change in Insulin Delivery System Rating Questionnaire - IDSRQ [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]A standardized questionnaire including several questions with ordinal response scales from 1 to 4 or 1 to 5. The IDSRQ has seven sub-scales (satisfaction, interference of treatment with daily activities, diabetes-related worries, clinical efficacy, psychological well-being, social burden, and treatment preference). Each sub-scale is calculated as a mean of their corresponding items with scores ranging from 0-100. Higher scores represent higher levels of satisfaction, perceived clinical efficacy, and psychological well-being, interference with daily activities, diabetes-related worries, and social burden.
- Change in Adherence to Refills and Medications Scale for Diabetes - ARMS-D [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]A standardized questionnaire including 11 multiple choice questions. The ARMS-D yields a total score plus two sub-scale scores (refill sub-scale and medication taking sub-scale. Items 1-10 are scored as follows: 1= none of the time, 2 = some of the time, 3 = most of the time, and 4 = all of the time. Item 11 is reversed scored. The ARMS-D total is a sum of all items for a possible score ranging from 11-44. The ARMS-D refill sub-scale is a sum of 4 items for a possible score ranging from 4-16. The ARMS-D medication taking sub-scale is a sum of 7 items for a possible score ranging from 7-28. Lower scores indicate better adherence.
- Patient Satisfaction [ Time Frame: Administered to participants in the Intervention group only at end of study (Day 56) ]A questionnaire including 16, 5-point Likert Scale questions where 1 indicates strongly disagree and 5 indicates strongly agree. This questionnaire yields a total satisfaction score plus three sub-scale scores (mobile app satisfaction, pen needle satisfaction, and injection management system satisfaction). The total score ranges from 16-80. The mobile app and pen needle satisfaction sub-scale score range from 6-30 and is a sum of all items in the associated sub-scale. The management system sub-scale score ranges from 4-20 and is a sum of all items in the sub-scale. Higher scores indicate higher satisfaction.
- Frequency of hypoglycemia [ Time Frame: Baseline (Day -14) to Study End (Day 56) ]Frequency of hypoglycemia: The number of hypoglycemic events (<70mg/dL and <54mg/dL) as measured by blood glucose monitor (BGM) will be collected to determine frequency of hypoglycemia in each group.
- Change in Patient Engagement [ Time Frame: Baseline (Day 1) to Study End (Day 56) ]
Patient Engagement: Engagement with The DC App will be measured by app collected usage analytics and will include assessments of time spent within app, frequency of opening the app, types of articles accessed, types of data logged, and frequency of article access or data logging.
- Within group comparisons of highly engaged app users compared to minimally engaged users will be performed for all outcomes listed in primary and secondary endpoint sections above.
- Injection Technique Questionnaire: [ Time Frame: Study end (Day 56) ]A questionnaire including 10 multiple choice questions. Each individual item is scored with either a 0 or 3. The total score ranges from 0 to 30 by summing all item scores together where a lower score indicates better injection technique.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090242
|Contact: Diane Sutter||19199497034||Diane_Sutter@bd.com|
|Contact: Edward Mahoney, Ph.D||978-901-7248||Edward.Mahoney@bd.com|
|United States, California|
|Mills Pennisula Medical Center-Diabetes Research Institute||Completed|
|San Mateo, California, United States, 94401|
|United States, Florida|
|Metabolic Research Institute||Recruiting|
|West Palm Beach, Florida, United States, 33401|
|Contact: Amy Clarke, BSN 561-802-3060 ext 8036 email@example.com|
|Principal Investigator: Barry Horowitz, MD|
|United States, Hawaii|
|East West Medical Research Institute||Completed|
|Honolulu, Hawaii, United States, 96814|
|United States, Texas|
|Texas Diabetes and Endocrinology||Completed|
|Austin, Texas, United States, 78749|