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

NCT03809858 | Completed

• 1 other identifier: 180034
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Klue; Meal bolus; Bolus reminder

Outcome Measures

Primary Outcomes (1)

• Number of missed meal boluses

  The change in the number of missed meal boluses

  During the two weeks prior to each visit

Secondary Outcomes (21)

• 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

  12 weeks

• Change in Hemoglobin A1c Levels

  3 months

• Time in range 70-180 mg/dL

  6 weeks

• Time in range 70-180 mg/dL

  12 weeks

Study Arms (2)

Klue App Use then Usual Care

EXPERIMENTAL

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

Usual Care then Klue App Use

EXPERIMENTAL

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

Interventions

Klue App OTHER

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.

Klue App Use then Usual Care; Usual Care then Klue App Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• Stanford University: collaborator
• Klue, Inc.: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related 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. doi: 10.1542/peds.113.3.e221.

  PMID: 14993580 BACKGROUND

• 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.

  PMID: 19175898 BACKGROUND

• 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.

  PMID: 21466646 BACKGROUND

• 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.

  PMID: 27234809 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marc Breton, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 18, 2019
• Study Start: May 29, 2019
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)