Clinical trial NCT03809858: Study to Test Efficacy of Real-time Reminders on Apple Watch 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: Diabetes Mellitus, Type 1
Keywords: Klue
Meal bolus
Bolus reminder
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Klue, Inc.
First posted: 2019-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be randomized to the sequence of completion in a 1:1 ratio. All subject will collect data throughout the study with half of them using the Klue App during the first 6 weeks and half using the Klue App during the second 6 weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no 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:

* Age 18 and over
* Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
* Willing to wear a CGM at least 70% of the time while in the study
* 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 2 weeks
* Understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria:

* Pregnant or lactating women
* A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
* Current treatment for a seizure disorder
* Inpatient psychiatric treatment in the past 6 months

Subject may participate in another trial if it is approved by the investigators of both trials.

Primary outcomes:
measure: Number of missed meal boluses
timeFrame: During the two weeks prior to each visit
Secondary outcomes:
measure: Number of missed meal boluses as a measure of attenuation to the alerts
timeFrame: 6 weeks
measure: Number of missed meal boluses as a measure of attenuation to the alerts
timeFrame: 12 weeks
measure: Change in Hemoglobin A1c Levels
timeFrame: 3 months
measure: Time in range 70-180 mg/dL
timeFrame: 6 weeks
measure: Time in range 70-180 mg/dL
timeFrame: 12 weeks
measure: Percent time <70 mg/dL mean glucose
timeFrame: 6 weeks
measure: Percent time <70 mg/dL mean glucose
timeFrame: 12 weeks
measure: Glucose Coefficient of Variation
timeFrame: 6 weeks
measure: Glucose Coefficient of Variation
timeFrame: 12 weeks
measure: Total daily insulin dose
timeFrame: 6 weeks
measure: Total daily insulin dose
timeFrame: 12 weeks
measure: Number of meal bolus injections each day
timeFrame: 6 weeks
measure: Number of meal bolus injections each day
timeFrame: 12 weeks
measure: Number of total bolus injections each day
timeFrame: 6 weeks
measure: Number of total bolus injections each day
timeFrame: 12 weeks
measure: Total daily basal insulin
timeFrame: 6 weeks
measure: Total daily basal insulin
timeFrame: 12 weeks
measure: Accuracy of Klue in detecting meals
timeFrame: 3 months
measure: User satisfaction of Klue
timeFrame: 3 months
measure: Diabetes-Specific Attitudes about Technology (DSAT) Scores
timeFrame: 3 months
measure: Diabetes Distress Scale (DDS) Scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Marc Breton, PhD
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.
citation: O'Connell MA, Donath S, Cameron FJ. Poor adherence to integral daily tasks limits the efficacy of CSII in youth. Pediatr Diabetes. 2011 Sep;12(6):556-9. doi: 10.1111/j.1399-5448.2010.00740.x. Epub 2011 Apr 6.
citation: Naranjo D, Tanenbaum ML, Iturralde E, Hood KK. Diabetes Technology: Uptake, Outcomes, Barriers, and the Intersection With Distress. J Diabetes Sci Technol. 2016 Jun 28;10(4):852-8. doi: 10.1177/1932296816650900. Print 2016 Jul.