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Completed

NCT Number: NCT03970889

Real-time Reminders To Decrease Late or Missed Meal Boluses

This study is examining whether the Klue app is effective in detecting missed or late meal boluses in patients with Type 1 diabetes. The app is programmed onto an Apple Watch and will detect potential missed boluses from hand motion. It will send text alerts to the user asking if they have bolused. This is a pilot study and will assess whether there is a change in the number of missed meal boluses in the two weeks prior to each visit. If the findings are significant, this software can be integrated in future closed-loop algorithms for automatic insulin delivery.

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Key information

Conditions

Type1 Diabetes Mellitus

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Palo Alto, California, 94305, United States

About this study

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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 13 and over
  • On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
  • Willing to wear a CGM at least 70% of the time while in the study
  • Using an iPhone
  • 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 two weeks
  • Understanding and willingness to follow the protocol and sign informed consent
  • Ability to speak, read and write in the language of the investigators

Exclusion criteria

  • Pregnant or lactating
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
  • Current treatment for a seizure disorder
  • Inpatient psychiatric treatment in the past 6 months

Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment. They may be participating in another trial, if this study is approved by the investigators of the other trial.

Treatment and study plan

Klue

Device

Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.

Primary outcomes

  1. Change in the number of missed meal boluses

    Time frame: The two weeks prior to each study visit

    A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.

Secondary outcomes

  1. Change in time in range

    Time frame: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject

    sensor glucose values between 70-180 mg/dl

  2. Positive predictive value of a Klue meal alert

    Time frame: All data for the 6 weeks on the Klue intervention arm when Klue is active

    Percent of time a meal alert signaled a meal

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: Klue

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2019
Registry last updated
Sep 2, 2021

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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