- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090242
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Mateo, California, United States, 94401
- Mills Pennisula Medical Center-Diabetes Research Institute
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Florida
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West Palm Beach, Florida, United States, 33401
- Metabolic Research Institute
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Hawaii
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Honolulu, Hawaii, United States, 96814
- East West Medical Research Institute
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Texas
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Austin, Texas, United States, 78749
- Texas Diabetes and Endocrinology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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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.
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NO_INTERVENTION: Standard Care
Standard of Care/Subject is to continue on their current diabetes management regime
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Attitude Toward Diabetes - Diabetes Empowerment Scale (DES) From Baseline to End of Study
Time Frame: Baseline (Day -14) and Study End (Day 56)
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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.
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Baseline (Day -14) and Study End (Day 56)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 24 Hour Average Blood Glucose From Baseline to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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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.
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Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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Blood Glucose Values in Range of <54 mg/dL at Baseline Compared to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end.
For example, Time below 54 mg/dl is calculated in the following manner: Number of all glucose data points below 54 mg/dl / total number of glucose data points X 100.
Since data points are all 5 minutes apart, this calculation provides the percentage of time in that range.
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Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Blood Glucose Values in Range of <70 mg/dL at Baseline Compared to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
|
Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end.
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Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Blood Glucose Values Between 70 mg/dL and 180 mg/dL at Baseline Compared to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end.
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Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Blood Glucose Values in Range of >180mg/dL at Baseline Compared to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
|
Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end.
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Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Blood Glucose Values in Range of >250 mg/dL at Baseline Compared to End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Data collected by the flash glucose monitor were used to calculate percent of time in range to compare differences between groups at baseline and study end.
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Baseline (Day -14 through Day -1) and Study End (Day 42-through Day 56)
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Change in Mean Amplitude of Glycemic Excursion (MAGE) Between Baseline and End of Study
Time Frame: Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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Flash glucose monitoring data were used to measure glycemic variability changes at baseline and study end between groups.
Measuring glycemic variability helps determine how much glucose levels change over the course of a day or between days.
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Baseline (Day -14 through Day -1) and Study End (Day 42 through Day 56)
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Change in Diabetes Distress Screening Scale - 17 (DDS17) Scores From Baseline to End of Study
Time Frame: Baseline (Day -14) to Study End (Day 56)
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A standardized questionnaire including 17, 6-point Likert Scale questions where 1 indicates "Not a problem", 2 indicates "A slight problem", 3 means "A moderate problem", 4 indicates a "Somewhat serious problem", 5 indicates "A serious problem", and 6 means "A very serious problem".
Using this scale, a Total Score, Emotional Burden Score, Physician Score, Regimen Distress Score, and Interpersonal Score were calculated.
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Baseline (Day -14) to Study End (Day 56)
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Insulin Delivery System Rating Questionnaire (IDSRQ) Scores at Baseline and End of Study
Time Frame: Baseline (Day -14) and Study End (Day 56)
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A standardized questionnaire including several questions with ordinal response scales from 1 to 4 and 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.
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Baseline (Day -14) and Study End (Day 56)
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Adherence to Refills and Medications Scale for Diabetes (ARMS-D) Questionnaire Scores at Baseline and Study End
Time Frame: Baseline (Day -14) to Study End (Day 56)
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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.
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Baseline (Day -14) to Study End (Day 56)
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Patient Satisfaction at Study End
Time Frame: Administered to participants in the Intervention group only at end of study (Day 56)
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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.
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Administered to participants in the Intervention group only at end of study (Day 56)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Hypoglycemic Events (<70mg/dL and <54mg/dL) at Baseline and Study End
Time Frame: Baseline (Day -14) to Study End (Day 56)
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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.
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Baseline (Day -14) to Study End (Day 56)
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Number of Hours of Patient Engagement With App
Time Frame: Baseline (Day 1) to Study End (Day 56)
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Patient Engagement: Engagement with The DC App will be measured by app collected usage analytics and main assessment was time spent within app.
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Baseline (Day 1) to Study End (Day 56)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Edward Mahoney, PhD, Becton Dickinson
- Principal Investigator: David Klonoff, M.D, FACP, Diabetes Research Institute, Mills-Peninsula Medical Center, California
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBC-19BRGHT02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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