Diabetes, Type 1EASI-IDMNCT02214719
Edmonton Automated Sugar Intelligence - Intelligent Diabetes Management, EASI-IDM, App Program to Assist Diabetes Care
A study testing EASI-IDM use in people with Diabetes, Type 1, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Type 1
- What is being tested?
- EASI-IDM use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes Smart phone user Resident of Canada
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes, Type 1
- Being tested
- EASI-IDM use
- Keywords
- type 1 diabetes, insulin therapy, bolus calculator
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASI-IDM useBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Baseline observation for EASI-IDM use | Experimental | Baseline observation period to gather information on current practice about diabetes care Receives: Behavioral: EASI-IDM use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control - A1c
Assess if A1c improves over course of study
Measured: 6 months
Secondary outcomes (4)
Use of the app
Number of glucose determinations recorded in the app per week per participant
Measured: 6 months
Patient initiated changes to insulin regimen
Number of patient initiated changes in subjects regimen per week
Measured: 6 months
Acceptance of app
Score on a visual analogue scale of acceptance of app by participants
Measured: 6 months
Long term use
Percentage of participants continuing to use app one month after formal end of intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes, Type 1Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmond Ryan, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214719
- Sponsor's protocol ID
- EASI02IDM01
- Acronym
- EASI-IDM
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2014
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27570203
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edmonton Automated Sugar Intelligence for Intelligent Diabetes Management, (EASI-IDM), a Computer Program to Assist People With Diabetes.
- ClinicalTrials.gov ID
- NCT02214719
- Acronym / sponsor ID
- EASI-IDM / EASI02IDM01
- Conditions
- Diabetes, Type 1
- Keywords
- type 1 diabetes, insulin therapy, bolus calculator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline observation for EASI-IDM use | Experimental | Behavioral: EASI-IDM useBaseline observation period to gather information on current practice about diabetes care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 1 diabetes Smart phone user Resident of Canada
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EASI-IDM useEASI-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. | Behavioural | Baseline observation for EASI-IDM use |
Primary outcome
Glucose control - A1c
Time frame: 6 months
Assess if A1c improves over course of study
4 secondary outcomes
Use of the app
Time frame: 6 months
Patient initiated changes to insulin regimen
Time frame: 6 months
Acceptance of app
Time frame: 6 months
Long term use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Results publication: PubMed 27570203Ryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmond Ryan, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EASI-IDM use in people with Diabetes, Type 1, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose control - A1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.