Real-time Reminders To Decrease Late or Missed Meal Boluses

Not Recruiting

Trial ID: NCT03970889


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.

Official Title

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

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus


Inclusion Criteria:

   1. Age 13 and over

   2. On an insulin pump for at least 3 months and using CGM or using an insulin pen with
   memory and a CGM

   3. Willing to wear a CGM at least 70% of the time while in the study

   4. Using an iPhone

   5. Willing to wear an Apple watch on their dominant hand while awake

   6. Missing or late in giving at least four food boluses in the previous two weeks

   7. Understanding and willingness to follow the protocol and sign informed consent

   8. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

   1. Pregnant or lactating

   2. A known medical condition that in the judgment of the investigator might interfere
   with the completion of the protocol

   3. Current treatment for a seizure disorder

   4. 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.


device: Klue

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Liana Hsu, BA