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

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ClinicalTrials.gov Identifier: NCT02214719
Recruitment Status : Unknown
Verified April 2016 by Edmond A Ryan, University of Alberta.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Edmond A Ryan, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Diabetes, Type 1 Behavioral: EASI-IDM use Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Edmonton Automated Sugar Intelligence for Intelligent Diabetes Management, (EASI-IDM), a Computer Program to Assist People With Diabetes.
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Glucose control - A1c [ Time Frame: 6 months ]
    Assess if A1c improves over course of study


Secondary Outcome Measures :
  1. Use of the app [ Time Frame: 6 months ]
    Number of glucose determinations recorded in the app per week per participant

  2. Patient initiated changes to insulin regimen [ Time Frame: 6 months ]
    Number of patient initiated changes in subjects regimen per week

  3. Acceptance of app [ Time Frame: 6 months ]
    Score on a visual analogue scale of acceptance of app by participants

  4. Long term use [ Time Frame: 6 months ]
    Percentage of participants continuing to use app one month after formal end of intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes Smart phone user Resident of Canada

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214719


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 1S2
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Edmond Ryan, MD University of Alberta

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Responsible Party: Edmond A Ryan, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT02214719    
Other Study ID Numbers: EASI02IDM01
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Keywords provided by Edmond A Ryan, University of Alberta:
type 1 diabetes, insulin therapy, bolus calculator
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases