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

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ClinicalTrials.gov Identifier: NCT03809858
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Marc Breton, University of Virginia

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




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)



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

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): NCT03809858


Contacts
Contact: Laura Kollar, RN 434-982-6479 llk7m@hscmail.mcc.virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Laura Kollar, RN    434-982-6479    llk7m@hscmail.mcc.virginia.edu   
Principal Investigator: Marc Breton, PhD         
Sub-Investigator: Sue Brown, MD         
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Marc Breton, PhD University of Virginia

Publications:
Responsible Party: Marc Breton, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03809858     History of Changes
Other Study ID Numbers: 180034
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marc Breton, University of Virginia:
Klue
Meal bolus
Bolus reminder

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases