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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes, Type 1||Behavioral: EASI-IDM use||Not Applicable|
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 :||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|
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.
- Glucose control - A1c [ Time Frame: 6 months ]Assess if A1c improves over course of study
- Use of the app [ Time Frame: 6 months ]Number of glucose determinations recorded in the app per week per participant
- Patient initiated changes to insulin regimen [ Time Frame: 6 months ]Number of patient initiated changes in subjects regimen per week
- Acceptance of app [ Time Frame: 6 months ]Score on a visual analogue scale of acceptance of app by participants
- Long term use [ Time Frame: 6 months ]Percentage of participants continuing to use app one month after formal end of intervention
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
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 1S2|
|Principal Investigator:||Edmond Ryan, MD||University of Alberta|