NCT02214719

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 14, 2023

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

August 1, 2014

Last Update Submit

February 10, 2023

Conditions

Keywords

type 1 diabetes, insulin therapy, bolus calculator

Outcome Measures

Primary Outcomes (1)

  • Glucose control - A1c

    Assess if A1c improves over course of study

    6 months

Secondary Outcomes (4)

  • Use of the app

    6 months

  • Patient initiated changes to insulin regimen

    6 months

  • Acceptance of app

    6 months

  • Long term use

    6 months

Study Arms (1)

Baseline observation for EASI-IDM use

EXPERIMENTAL

Baseline observation period to gather information on current practice about diabetes care

Behavioral: EASI-IDM use

Interventions

EASI-IDM useBEHAVIORAL

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.

Baseline observation for EASI-IDM use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes Smart phone user Resident of Canada

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 1S2, Canada

Location

Related Publications (1)

  • Ryan EA, Holland J, Stroulia E, Bazelli B, Babwik SA, Li H, Senior P, Greiner R. Improved A1C Levels in Type 1 Diabetes with Smartphone App Use. Can J Diabetes. 2017 Feb;41(1):33-40. doi: 10.1016/j.jcjd.2016.06.001. Epub 2016 Aug 25.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Edmond Ryan, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 12, 2014

Study Start

August 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 14, 2023

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations