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Real-time Reminders To Decrease Late or Missed Meal Boluses (Klue)

Primary Purpose

Type1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Klue

About this trial

This is an interventional supportive care trial for Type1 Diabetes Mellitus

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Klue

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in time in range

sensor glucose values between 70-180 mg/dl

Positive predictive value of a Klue meal alert

Percent of time a meal alert signaled a meal

Full Information

NCT ID

NCT03970889

First Posted

August 23, 2018

Last Updated

August 31, 2021

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03970889

Brief Title

Real-time Reminders To Decrease Late or Missed Meal Boluses

Acronym

Klue

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 12, 2018 (Actual)

Primary Completion Date

March 19, 2020 (Actual)

Study Completion Date

March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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) and insulin pumps or an insulin pen with memory and CGM, are missing or late in giving at least 4 food boluses in the previous two weeks, and they have an iPhone. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. The investigators do not have 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

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

Arm Title

Klue

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Klue

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the number of missed meal boluses

Description

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

Time Frame

The two weeks prior to each study visit

Secondary Outcome Measure Information:

Title

Change in time in range

Description

sensor glucose values between 70-180 mg/dl

Time Frame

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

Title

Positive predictive value of a Klue meal alert

Description

Percent of time a meal alert signaled a meal

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

14993580

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.

Results Reference

background

PubMed Identifier

19175898

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.

Results Reference

background

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Real-time Reminders To Decrease Late or Missed Meal Boluses

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