Real-time Reminders To Decrease Late or Missed Meal Boluses

Completed · Not applicable

Conditions studied: Type1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03970889

Run by

Stanford University

People needed

24

Starts

2018-10-12

Expected to finish

2020-03-30

Last updated by the study team

2021-09-02

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Stanford — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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