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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Other: Klue App

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Klue App Use then Usual Care; Subjects will use the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will discontinue Klue App use and will continue the final 6 weeks without the product.	Other: Klue App; The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
Experimental: Usual Care then Klue App Use; Subjects will begin the study without using the Klue App during the first 6 weeks of the trial. At 6 weeks, subjects will begin the use of the Klue App and will continue the final 6 weeks with the product.	Other: Klue App; The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of missed meal boluses	The change in the number of missed meal boluses	During the two weeks prior to each visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of missed meal boluses as a measure of attenuation to the alerts	The change in the number of missed meal boluses as a measure of attenuation to the alerts	6 weeks
Number of missed meal boluses as a measure of attenuation to the alerts	The change in the number of missed meal boluses as a measure of attenuation to the alerts	12 weeks
Change in Hemoglobin A1c Levels	Change in Hemoglobin A1c Levels	3 months
Time in range 70-180 mg/dL	Time in range 70-180 mg/dL as measured by CGM	6 weeks
Time in range 70-180 mg/dL	Time in range 70-180 mg/dL as measured by CGM	12 weeks
Percent time <70 mg/dL mean glucose	Percent time <70 mg/dL mean glucose as measured by CGM	6 weeks
Percent time <70 mg/dL mean glucose	Percent time <70 mg/dL mean glucose as measured by CGM	12 weeks
Glucose Coefficient of Variation	Glucose (as measured by CGM) Coefficient of Variation	6 weeks
Glucose Coefficient of Variation	Glucose (as measured by CGM) Coefficient of Variation	12 weeks
Total daily insulin dose	Total daily insulin dose	6 weeks
Total daily insulin dose	Total daily insulin dose	12 weeks
Number of meal bolus injections each day	Number of meal bolus injections each day	6 weeks
Number of meal bolus injections each day	Number of meal bolus injections each day	12 weeks
Number of total bolus injections each day	Number of total bolus injections each day	6 weeks
Number of total bolus injections each day	Number of total bolus injections each day	12 weeks
Total daily basal insulin	Total daily basal insulin	6 weeks
Total daily basal insulin	Total daily basal insulin	12 weeks
Accuracy of Klue in detecting meals	Accuracy of Klue in detecting meals (true positive and false positive rates)	3 months
User satisfaction of Klue	User satisfaction of Klue	3 months
Diabetes-Specific Attitudes about Technology (DSAT) Scores	DSAT Scores (Scaled from "Strongly Disagree" to "Strongly Agree" in relation to attitudes related to technology in diabetes treatment)	3 months
Diabetes Distress Scale (DDS) Scores	DDS Scores (Scaled from "Not a Problem" to "A Very Serious Problem" in relation to feelings/mood related to diabetes)	3 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Stanford University; Klue, Inc.
• Investigators: Principal Investigator: Marc Breton, PhD, University of Virginia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Klue; Meal bolus; Bolus reminder
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 180034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No