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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809858
• Other study ID #: 180034
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: April 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Klue, Inc., Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of missed meal boluses	The change in the number of missed meal boluses	During the two weeks prior to each visit
Secondary	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
Secondary	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
Secondary	Change in Hemoglobin A1c Levels	Change in Hemoglobin A1c Levels	3 months
Secondary	Time in range 70-180 mg/dL	Time in range 70-180 mg/dL as measured by CGM	6 weeks
Secondary	Time in range 70-180 mg/dL	Time in range 70-180 mg/dL as measured by CGM	12 weeks
Secondary	Percent time <70 mg/dL mean glucose	Percent time <70 mg/dL mean glucose as measured by CGM	6 weeks
Secondary	Percent time <70 mg/dL mean glucose	Percent time <70 mg/dL mean glucose as measured by CGM	12 weeks
Secondary	Glucose Coefficient of Variation	Glucose (as measured by CGM) Coefficient of Variation	6 weeks
Secondary	Glucose Coefficient of Variation	Glucose (as measured by CGM) Coefficient of Variation	12 weeks
Secondary	Total daily insulin dose	Total daily insulin dose	6 weeks
Secondary	Total daily insulin dose	Total daily insulin dose	12 weeks
Secondary	Number of meal bolus injections each day	Number of meal bolus injections each day	6 weeks
Secondary	Number of meal bolus injections each day	Number of meal bolus injections each day	12 weeks
Secondary	Number of total bolus injections each day	Number of total bolus injections each day	6 weeks
Secondary	Number of total bolus injections each day	Number of total bolus injections each day	12 weeks
Secondary	Total daily basal insulin	Total daily basal insulin	6 weeks
Secondary	Total daily basal insulin	Total daily basal insulin	12 weeks
Secondary	Accuracy of Klue in detecting meals	Accuracy of Klue in detecting meals (true positive and false positive rates)	3 months
Secondary	User satisfaction of Klue	User satisfaction of Klue	3 months
Secondary	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
Secondary	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