Diabetes Mellitus, Diabetes Mellitus, Type 1
Conditions
Keywords
Multiple Daily Injections,, Type 1 diabetes, Optimization algorithm
Brief 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.
Detailed 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.
Interventions
DEVICEMobile 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.
DEVICEMobile 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.
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, randomized, controlled, two-way parallel study to compare glucose control between sensor-augmented MDI therapy and our basal-bolus optimizing algorithm over 3 months. Adults with type 1 diabetes who are enrolled in the study will randomly undergo one of the two interventions for the entire study duration.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c levels | Pre-intervention and post-intervention, approximately 12 weeks | Difference in HbA1c levels from the start to the end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of overnight time (23:00-7:00) of sensor glucose levels: | 12 weeks | 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. |
| Standard deviation of glucose levels. | 12 weeks | Standard deviation of glucose levels as a measure of glucose variability. |
| Total insulin delivery. | 12 weeks | Total insulin delivery |
| Mean sensor glucose level during: | 12 weeks | a. the overall study period; b. the daytime period; c. overnight period. |
| The number of patients that achieve an HbA1c at the end-of-study visit of: | Post-intervention, approximately 12 weeks | a. less than or equal to 7.0%; b. less than or equal to 6.5% |
| Percentage of time of sensor glucose levels spent: | 12 weeks | 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. |
| Percentage of daytime (7:00-23:00) of sensor glucose levels: | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recurrent themes from semi-structured interviews | Post-intervention, approximately 12 weeks | 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. |
| Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire | Pre-intervention, then monthly, approximately 12 weeks | Scoring for treatment satisfaction ranges from 0-6; higher score = higher satisfaction (patient-reported outcomes) |
| Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire | Post-intervention, approximately 12 weeks | Scoring for the usability of the app ranges from 1-7; higher score = higher usability (patient-reported outcomes) |
Countries
Canada
Outcome results
None listed