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Completed

NCT Number: NCT03809858

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Klue App

Other

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Klue, Inc.
  • Stanford University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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