Real-time Reminders To Decrease Late or Missed Meal Boluses (Klue)
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ClinicalTrials.gov Identifier: NCT03970889 |
Recruitment Status :
Completed
First Posted : June 3, 2019
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Type1 Diabetes Mellitus | Device: Klue | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Subjects are randomized so that half will use the Klue App in the first 6 weeks of the study, and half will use the Klue App during the second 6 weeks of the study. |
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 : | October 12, 2018 |
Actual Primary Completion Date : | March 19, 2020 |
Actual Study Completion Date : | March 30, 2020 |

Arm | Intervention/treatment |
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No Intervention: Standard Care
Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory
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Experimental: Klue
Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.
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Device: Klue
Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating. |
- 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.
- 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
- 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

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Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT03970889
United States, California | |
Stanford | |
Palo Alto, California, United States, 94305 |
Principal Investigator: | Bruce Buckingham, MD | Stanford University |
Responsible Party: | Bruce Buckingham, Professor of Pediatric Endocrinology, Stanford University |
ClinicalTrials.gov Identifier: | NCT03970889 |
Other Study ID Numbers: |
47137 |
First Posted: | June 3, 2019 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |