A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users

Diabetes Mellitus Clinical Trial

Official title:

An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Effectiveness of Multiple Daily Injection Treatment With an Insulin Dose Optimization Algorithm in Free-Living Outpatient Conditions in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123054
• Other study ID #: 2020-5887
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: January 12, 2024

Study information

• Verified date: May 2024
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.

Description:

The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates.

Inclusion: HbA1c ≥ 7.5% in the last 2 months (modification)

Exclusion:

• More than 1 slow-acting injection and unwilling to switch to once a day for the study (addition)

• Severe hypoglycemic episode within one month of admission (addition)

In the subsequent amendment, we modified the timeframe for the HbA1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 12, 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females = 18 years of age

2. Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.

3. Undergoing multiple daily injection therapy.

4. Baseline HbA1c value = 7.5% (up to 7 days before or after screening).

Exclusion Criteria:

1. Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

2. Failure to comply with the study protocol or with the team's recommendations.

3. Injection of isophane insulin (NPH) or any intermediate-acting insulin

4. More than 1 slow-acting injection and unwilling to switch to once a day for the study

5. Current or = 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc.…).

6. Pregnancy

7. Severe hypoglycemic episode within one month of admission.

8. Severe diabetic ketoacidosis episode within one month of admission

9. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator

10. Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery

11. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Mobile App
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator.
• Mobile App + Basal-Bolus Optimization Algorithm
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator. In addition, participants will receive weekly app notifications with personalized recommendations for insulin parameter adjustments made by the optimization algorithm.

Locations

Country	Name	City	State
Canada	CIUSSS West-Central Montreal, Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire	Scoring for treatment satisfaction ranges from 0-6; higher score = higher satisfaction (patient-reported outcomes)	Pre-intervention, then monthly, approximately 12 weeks
Other	Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire	Scoring for the usability of the app ranges from 1-7; higher score = higher usability (patient-reported outcomes)	Post-intervention, approximately 12 weeks
Other	Recurrent themes from semi-structured interviews	Qualitative interview data to obtain an understanding of relationships by connecting lived experiences with a) mean survey scores and b) primary and secondary outcomes regarding the use of the study software on quality of life.	Post-intervention, approximately 12 weeks
Primary	Change in HbA1c levels	Difference in HbA1c levels from the start to the end of the study	Pre-intervention and post-intervention, approximately 12 weeks
Secondary	The number of patients that achieve an HbA1c at the end-of-study visit of:	a. less than or equal to 7.0%; b. less than or equal to 6.5%	Post-intervention, approximately 12 weeks
Secondary	Percentage of time of sensor glucose levels spent:	a. between 3.9 and 7.8 mmol/L; b.between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d.below 3.3 mmol/L; e.below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.	12 weeks
Secondary	Percentage of overnight time (23:00-7:00) of sensor glucose levels:	a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c.below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.	12 weeks
Secondary	Percentage of daytime (7:00-23:00) of sensor glucose levels:	a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.	12 weeks
Secondary	Standard deviation of glucose levels.	Standard deviation of glucose levels as a measure of glucose variability.	12 weeks
Secondary	Total insulin delivery.	Total insulin delivery	12 weeks
Secondary	Mean sensor glucose level during:	a. the overall study period; b. the daytime period; c. overnight period.	12 weeks