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出境医 / 临床实验 / Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Study Description
Brief Summary:
This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Other: Klue App Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : November 18, 2019
Actual Study Completion Date : November 18, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Klue App Use then Usual Care
Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.
 Other: Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
Experimental: Usual Care then Klue App Use
Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.
 Other: Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
Outcome Measures
Primary Outcome Measures :
  1. Number of missed meal boluses [ Time Frame: During the two weeks prior to each visit ]
    The change in the number of missed meal boluses


Secondary Outcome Measures :
  1. Number of missed meal boluses as a measure of attenuation to the alerts [ Time Frame: 6 weeks ]
    The change in the number of missed meal boluses as a measure of attenuation to the alerts

  2. Number of missed meal boluses as a measure of attenuation to the alerts [ Time Frame: 12 weeks ]
    The change in the number of missed meal boluses as a measure of attenuation to the alerts

  3. Change in Hemoglobin A1c Levels [ Time Frame: 3 months ]
    Change in Hemoglobin A1c Levels

  4. Time in range 70-180 mg/dL [ Time Frame: 6 weeks ]
    Time in range 70-180 mg/dL as measured by CGM

  5. Time in range 70-180 mg/dL [ Time Frame: 12 weeks ]
    Time in range 70-180 mg/dL as measured by CGM

  6. Percent time <70 mg/dL mean glucose [ Time Frame: 6 weeks ]
    Percent time <70 mg/dL mean glucose as measured by CGM

  7. Percent time <70 mg/dL mean glucose [ Time Frame: 12 weeks ]
    Percent time <70 mg/dL mean glucose as measured by CGM

  8. Glucose Coefficient of Variation [ Time Frame: 6 weeks ]
    Glucose (as measured by CGM) Coefficient of Variation

  9. Glucose Coefficient of Variation [ Time Frame: 12 weeks ]
    Glucose (as measured by CGM) Coefficient of Variation

  10. Total daily insulin dose [ Time Frame: 6 weeks ]
    Total daily insulin dose

  11. Total daily insulin dose [ Time Frame: 12 weeks ]
    Total daily insulin dose

  12. Number of meal bolus injections each day [ Time Frame: 6 weeks ]
    Number of meal bolus injections each day

  13. Number of meal bolus injections each day [ Time Frame: 12 weeks ]
    Number of meal bolus injections each day

  14. Number of total bolus injections each day [ Time Frame: 6 weeks ]
    Number of total bolus injections each day

  15. Number of total bolus injections each day [ Time Frame: 12 weeks ]
    Number of total bolus injections each day

  16. Total daily basal insulin [ Time Frame: 6 weeks ]
    Total daily basal insulin

  17. Total daily basal insulin [ Time Frame: 12 weeks ]
    Total daily basal insulin

  18. Accuracy of Klue in detecting meals [ Time Frame: 3 months ]
    Accuracy of Klue in detecting meals (true positive and false positive rates)

  19. User satisfaction of Klue [ Time Frame: 3 months ]
    User satisfaction of Klue

  20. Diabetes-Specific Attitudes about Technology (DSAT) Scores [ Time Frame: 3 months ]
    DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)

  21. Diabetes Distress Scale (DDS) Scores [ Time Frame: 3 months ]
    DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and over
  • Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
  • Willing to wear a CGM at least 70% of the time while in the study
  • Willing to wear an Apple watch on their dominant hand while awake
  • Missing or late in giving at least four food boluses in the previous 2 weeks
  • Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  • Current treatment for a seizure disorder
  • Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.

Contacts and Locations

Locations
Layout table for location information
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Stanford University
Klue, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Marc Breton, PhD University of Virginia
Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE May 29, 2019
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019) 		Number of missed meal boluses [ Time Frame: During the two weeks prior to each visit ]
The change in the number of missed meal boluses
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Number of missed meal boluses as a measure of attenuation to the alerts [ Time Frame: 6 weeks ]
    The change in the number of missed meal boluses as a measure of attenuation to the alerts
  • Number of missed meal boluses as a measure of attenuation to the alerts [ Time Frame: 12 weeks ]
    The change in the number of missed meal boluses as a measure of attenuation to the alerts
  • Change in Hemoglobin A1c Levels [ Time Frame: 3 months ]
    Change in Hemoglobin A1c Levels
  • Time in range 70-180 mg/dL [ Time Frame: 6 weeks ]
    Time in range 70-180 mg/dL as measured by CGM
  • Time in range 70-180 mg/dL [ Time Frame: 12 weeks ]
    Time in range 70-180 mg/dL as measured by CGM
  • Percent time <70 mg/dL mean glucose [ Time Frame: 6 weeks ]
    Percent time <70 mg/dL mean glucose as measured by CGM
  • Percent time <70 mg/dL mean glucose [ Time Frame: 12 weeks ]
    Percent time <70 mg/dL mean glucose as measured by CGM
  • Glucose Coefficient of Variation [ Time Frame: 6 weeks ]
    Glucose (as measured by CGM) Coefficient of Variation
  • Glucose Coefficient of Variation [ Time Frame: 12 weeks ]
    Glucose (as measured by CGM) Coefficient of Variation
  • Total daily insulin dose [ Time Frame: 6 weeks ]
    Total daily insulin dose
  • Total daily insulin dose [ Time Frame: 12 weeks ]
    Total daily insulin dose
  • Number of meal bolus injections each day [ Time Frame: 6 weeks ]
    Number of meal bolus injections each day
  • Number of meal bolus injections each day [ Time Frame: 12 weeks ]
    Number of meal bolus injections each day
  • Number of total bolus injections each day [ Time Frame: 6 weeks ]
    Number of total bolus injections each day
  • Number of total bolus injections each day [ Time Frame: 12 weeks ]
    Number of total bolus injections each day
  • Total daily basal insulin [ Time Frame: 6 weeks ]
    Total daily basal insulin
  • Total daily basal insulin [ Time Frame: 12 weeks ]
    Total daily basal insulin
  • Accuracy of Klue in detecting meals [ Time Frame: 3 months ]
    Accuracy of Klue in detecting meals (true positive and false positive rates)
  • User satisfaction of Klue [ Time Frame: 3 months ]
    User satisfaction of Klue
  • Diabetes-Specific Attitudes about Technology (DSAT) Scores [ Time Frame: 3 months ]
    DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)
  • Diabetes Distress Scale (DDS) Scores [ Time Frame: 3 months ]
    DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Official Title  ICMJE Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Brief Summary This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE Other: Klue App
The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
Study Arms  ICMJE
  • Experimental: Klue App Use then Usual Care
    Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.
    Intervention: Other: Klue App
  • Experimental: Usual Care then Klue App Use
    Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.
    Intervention: Other: Klue App
Publications *
  • Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4.
  • Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.
  • O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Pediatr Diabetes. 2011 Sep;12(6):556-9. doi: 10.1111/j.1399-5448.2010.00740.x. Epub 2011 Apr 6.
  • Naranjo D, Tanenbaum ML, Iturralde E, Hood KK. Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. J Diabetes Sci Technol. 2016 Jun 28;10(4):852-8. doi: 10.1177/1932296816650900. Print 2016 Jul. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2020) 		12
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2019) 		15
Actual Study Completion Date  ICMJE November 18, 2019
Actual Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 and over
  • Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
  • Willing to wear a CGM at least 70% of the time while in the study
  • Willing to wear an Apple watch on their dominant hand while awake
  • Missing or late in giving at least four food boluses in the previous 2 weeks
  • Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
  • Current treatment for a seizure disorder
  • Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809858
Other Study ID Numbers  ICMJE 180034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data
Responsible Party Marc Breton, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • Stanford University
  • Klue, Inc.
Investigators  ICMJE
Principal Investigator: Marc Breton, PhD University of Virginia
PRS Account University of Virginia
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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