Real-time Reminders To Decrease Late or Missed Meal Boluses

NCT03970889 | Completed

• 1 other identifier: 47137
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in the number of missed meal boluses

  A missed meal bolus is defined by no insulin dose within 2 hours from the start of the CGM rise.

  The two weeks prior to each study visit

Secondary Outcomes (2)

• Change in time in range

  data for 1 month prior to each study visit at baseline, 6 weeks and 12 weeks of this 12 week study for each subject

• Positive predictive value of a Klue meal alert

  All data for the 6 weeks on the Klue intervention arm when Klue is active

Study Arms (2)

Standard Care

NO INTERVENTION

Participants will be in their usual care, wearing a continuous glucose sensor and taking insulin by pump or by pens with memory

Klue

EXPERIMENTAL

Subjects will wear an Apple watch on their dominant hand and receive alerts when eating behavior is detected by the Klue software.

Device: Klue

Interventions

Klue DEVICE

Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.

Klue

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 13 and over
• On an insulin pump for at least 3 months and using CGM or using an insulin pen with memory and a CGM
• Willing to wear a CGM at least 70% of the time while in the study
• Using an iPhone
• 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 two weeks
• Understanding and willingness to follow the protocol and sign informed consent
• Ability to speak, read and write in the language of the investigators

You may not qualify if:

• Pregnant or lactating
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• Current treatment for a seizure disorder
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Palo Alto, California, 94305, United States

Location

Related Publications (2)

• 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

Study Officials

• Bruce Buckingham, MD

  Stanford University

  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: Professor of Pediatric Endocrinology

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: June 3, 2019
• Study Start: October 12, 2018
• Primary Completion: March 19, 2020
• Study Completion: March 30, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)