Your session is about to expire
← Back to Search
Mobile App + Basal-Bolus Optimization Algorithm for Diabetes
N/A
Recruiting
Led By Michael Tsoukas, MD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention, then monthly, approximately 12 weeks
Awards & highlights
Study Summary
This trial is testing an algorithm to help improve long-term glycemic targets for adults with Type 1 Diabetes by reducing HbA1c levels.
Eligible Conditions
- Diabetes
- Type 1 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention, then monthly, approximately 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention, then monthly, approximately 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in HbA1c levels
Secondary outcome measures
Glucose
Percentage of daytime (7:00-23:00) of sensor glucose levels
Percentage of overnight time (23:00-7:00) of sensor glucose levels
+4 moreOther outcome measures
Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire
Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire
Recurrent themes from semi-structured interviews
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization AlgorithmExperimental Treatment1 Intervention
Participants will undergo multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data. Every week, participants' insulin doses will be updated by the optimization algorithm's recommendations.
Group II: Sensor-Augmented MDI + Mobile App (control)Active Control1 Intervention
Participants will continue their usual multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data.
Find a Location
Who is running the clinical trial?
McGill UniversityLead Sponsor
394 Previous Clinical Trials
998,297 Total Patients Enrolled
2 Trials studying Diabetes
95 Patients Enrolled for Diabetes
Michael Tsoukas, MDPrincipal InvestigatorRI-MUHC
4 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You take multiple injections per day.You have been diagnosed with type 1 diabetes for at least one year according to your doctor. Testing for C peptide levels or antibodies is not necessary.You are 18 years old or older, regardless of your gender.Your blood sugar control, as measured by HbA1c, is higher than 7.5%.
Research Study Groups:
This trial has the following groups:- Group 1: Sensor-Augmented MDI + Mobile App (control)
- Group 2: Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger