Real-time Reminders To Decrease Late or Missed Meal Boluses (Klue)

Stanford University

Status: Completed

Conditions: Type1 Diabetes Mellitus

Treatments: Device: Klue

Study type: Interventional

Funder types: Other

Identifiers

NCT03970889

47137

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory

Klue

Experimental group

Description:

Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.

Treatment:

Device: Klue