Edmonton Automated Sugar Intelligence - Intelligent Diabetes Management, EASI-IDM, App Program to Assist Diabetes Care (EASI-IDM)

February 10, 2023 updated by: University of Alberta

Edmonton Automated Sugar Intelligence for Intelligent Diabetes Management, (EASI-IDM), a Computer Program to Assist People With Diabetes.

A closed loop system for diabetes care utilizing an insulin pump, continuous glucose sensing and appropriate mathematical modelling to guide insulin dosing is a goal for those with Type 1 diabetes. Yet the cost of the associated hardware will be prohibitive for many people with diabetes or their health care payers. Carbohydrate counting, insulin dose correction systems, basal bolus regimens with or without an insulin pump all facilitate glucose control but frequent adjustment to a diabetes regimen is a necessary cornerstone to successful diabetes management; if all that is used is the regimen suggested by the health care provider at a visit and this regimen is left unchanged until the next visit or contact then success will be limited. A readily available user friendly program suitable for a smart phone or tablet would have widespread applicability and benefit. The investigators hypothesize that such an app linked into a web site that facilitated review of glucose records will be acceptable to people with diabetes and improve glucose control. Our long term goal is to create an app that can advise on diabetes management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with Type 1 diabetes who use a smart phone will keep detailed records of their blood glucose readings, carbohydrate intake, activity and insulin doses and share them with us. The investigators have developed a smart phone app to facilitate the recording of glucose readings, Edmonton Automated Sugar Intelligence (EASI). This EASI app may be used on Android or iPhone platforms. It will link to a web site (Intelligent Diabetes Management-IDM) that houses the person's algorithm for their insulin adjustments ie their insulin regimen scale or correction factor equation, their carbohydrate ratio formula for each meal and snack, their appropriate adjustment for exercise so that entry of the timed glucose, the carbohydrate portion to be consumed and any expected activity will allow derivation of the appropriate insulin dose. This information will be entered into the EASI program associated web site by the clinical staff at the time off the visit to the diabetes program or recruitment to the study.

Then, the patient simply enters the current glucose and carbohydrate intake into EASI to allow the app use their prescribed algorithm and arrive at a suggested insulin dose. It is simply using the smart phone to do what is done by mental arithmetic or on paper at present. Thus EASI-IDM is a simple clinical decision support system to assist health management. The advantage is the information is stored in real time to the IDM web site for both the person or their caregiver to review.

Since weight, age, gender, renal function, phase of menstrual cycle and ambient glucose may have an impact on glycemic control the investigators will also record these details.

The first substudy planned is an - Acceptability sub study survey. The team has developed the EASI app that links in with the IDM web site. The investigators want to study how well it is accepted by patients with Type 1 diabetes, whether they use it on an ongoing basis, whether it leads to them adjusting their insulin regimen themselves more frequently and finally does it improve their A1c.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1S2
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes Smart phone user Resident of Canada

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Baseline observation for EASI-IDM use
Baseline observation period to gather information on current practice about diabetes care
Behavioral: EASI-IDM use
EASI-IDM use is the intervention involving the use of the Edmonton Automated Sugar Intelligence system linked to the Intelligent Diabetes Website by people with type 1 diabetes to facilitate glucose record keeping, clinical monitoring and we will assess if this app helps lead to improved glucose control and more patient involvement with their diabetes management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glucose control - A1c
Time Frame: 6 months
Assess if A1c improves over course of study
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of the app
Time Frame: 6 months
Number of glucose determinations recorded in the app per week per participant
6 months
Patient initiated changes to insulin regimen
Time Frame: 6 months
Number of patient initiated changes in subjects regimen per week
6 months
Acceptance of app
Time Frame: 6 months
Score on a visual analogue scale of acceptance of app by participants
6 months
Long term use
Time Frame: 6 months
Percentage of participants continuing to use app one month after formal end of intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edmond Ryan, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EASI02IDM01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings