Clinical trial NCT03970889: Real-time Reminders To Decrease Late or Missed Meal Boluses
Official title: Pilot Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the number of missed meal boluses
timeFrame: The two weeks prior to each study visit
Secondary outcomes:
measure: Change in time in range
timeFrame: data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject
measure: Positive predictive value of a Klue meal alert
timeFrame: All data for the 6 weeks on the Klue intervention arm when Klue is active
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burdick J, Chase HP, Slover RH, Knievel K, Scrimgeour L, Maniatis AK, Klingensmith GJ. Missed insulin meal boluses and elevated hemoglobin A1c levels in children receiving insulin pump therapy. Pediatrics. 2004 Mar;113(3 Pt 1):e221-4. doi: 10.1542/peds.113.3.e221.
citation: Olinder AL, Kernell A, Smide B. Missed bolus doses: devastating for metabolic control in CSII-treated adolescents with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):142-8. doi: 10.1111/j.1399-5448.2008.00462.x. Epub 2008 Oct 24.