An observational study of adults living with type 1 diabetes
| ISRCTN | ISRCTN11362144 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11362144 |
| Secondary identifying numbers | 2021-1110 |
- Submission date
- 10/03/2021
- Registration date
- 15/03/2021
- Last edited
- 22/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 1 diabetes causes the level of glucose (sugar) in your blood to become too high. It happens when your body cannot produce enough of a hormone called insulin, which controls blood glucose.
The advent of automated insulin delivery (AID) systems provides the potential to significantly improve diabetes management among people with Type 1 Diabetes.
The aim of this study is to assess whether do-it-yourself AID systems are equivalent to commercial AID systems in terms of effectiveness for glycemic control, safety and quality of life among adults living with type 1 diabetes in real-life conditions.
Who can participate?
To participate in this study, patients must have been living with Type 1 Diabetes for more than one year, be 18 years old and over, and have been using AID therapy for more than 3 months.
What does the study involve?
The study involves 5 visits that can be undertaken over approximately 12 weeks. Participants will wear an additional glucose sensor for 4 weeks and answer questionnaires to assess quality of life. At the end of those four weeks, we will ask them to return the additional glucose sensors to the research team.
What are the possible benefits and risks of participating?
Participants may obtain a personal benefit from participating in this research project, but we cannot guarantee it. The only direct benefit is the possibility to receive a refreshment education on how to manage acute hypo and hyperglycemic conditions. In addition, we hope that the results of this study will allow us to assess the comparative effectiveness and safety of various AID systems in type 1 diabetes.
Possible risks of participating include a risk of infection, irritation and/or slight discomfort at the points of insertion for the Dexcom G6 sensors; certain side effects associated with participants' medical condition and their AID therapy; hypoglycemia; and hyperglycemia.
Where is the study run from?
The study is being run from the Montreal Clinical Research Institute in Montreal, Québec, Canada.
When is the study starting and how long is it expected to run for?
December 2020 to March 2023
Who is funding the study?
The study is funded by the Canadian Institutes of Health Research
Who is the main contact?
Dr Rémi Rabasa-Lhoret, remi.rabasa-lhoret@ircm.qc.ca
Contact information
Scientific
Montreal Clinical Research Institute (IRCM)
110, avenue des Pins Ouest
Montreal
H2W 1R7
Canada
 ORCID ID |
0000-0003-4706-5170 |
|---|---|
| Phone | 514-987-5666 |
| remi.rabasa-lhoret@ircm.qc.ca |
Public
Montreal Clinical Research Institute (IRCM)
110, avenue des Pins Ouest
Montreal
H2W 1R7
Canada
| ORCID ID |
0000-0001-8362-596X |
|---|---|
| Phone | 514-987-5500, extension 3238 |
| anne.bonhoure@ircm.qc.ca |
Scientific
Montreal Clinical Research Institute (IRCM)
110, avenue des Pins Ouest
Montreal
H2W 1R7
Canada
| ORCID ID |
0000-0002-0671-1888 |
|---|---|
| Phone | 514-987-5500, extension 3238 |
| zekai.wu@mail.mcgill.ca |
Public
Montreal Clinical Research Institute (IRCM)
110, avenue des Pins Ouest
Montreal
H2W 1R7
Canada
| ORCID ID |
0000-0002-2506-6562 |
|---|---|
| Phone | 514-987-5500, extension 3227 |
| virginie.messier@ircm.qc.ca |
Study information
| Study design | Prospective single-center non-inferiority non-randomized parallel-cohort observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparison between two types of novel insulin delivery systems among adults living with type 1 diabetes |
| Study acronym | MILESTONE |
| Study hypothesis | Do-it-yourself automated insulin delivery therapy is non-inferior to commercial automated insulin delivery therapy in terms of effectiveness for glycemic control, safety and quality of life among adults living with type 1 diabetes in real-life conditions. |
| Ethics approval(s) | Approved 08/03/2021, Research Ethics Board of the Montreal Clinical Research Institute (110 Avenue des Pins West, Montréal, Québec, H2W 1R7, Canada; +1 (514) 987-5550; Brigitte.St-Pierre@ircm.qc.ca), ref: 2021-1110 |
| Condition | Type 1 diabetes |
| Intervention | This is an observational study. Participation in this research project will last approximately 12 weeks and will include 5 visits. Participants will wear an additional glucose sensor for 4 weeks and answer questionnaires to assess quality of life. |
| Intervention type | Other |
| Primary outcome measure | Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L (TIR%) measured using a worn glucose sensor over 4 weeks |
| Secondary outcome measures | Measured using a worn glucose sensor over 4 weeks: 1. Percentage of time of glucose levels. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. below 3.0 mmol/L; d. above 10.0 mmol/L; e. above 13.9 mmol/L 2. Mean glucose levels 3. Estimated HbA1c 4. Standard deviation (SD) and coefficient of variance (CV) of glucose levels 5. Episodes of hypoglycemia/hyperglycemia 6. Glucose area under the curve 7. Risk of hypoglycemia and hyperglycemia (low blood glucose index [LBGI] and high blood glucose index [HBGI]) measured using data from the glucose sensor over 4 weeks 8. Scores for QoL questionnaires (Hypoglycemia Fear Survey II, Diabetes Distress Scale, Diabetes Treatment Satisfaction Questionnaire, Pittsburgh Sleep Quality Index, and Audit of Diabetes Dependent Quality of Life) at baseline 9. SD and CV of insulin delivery measured using insulin records of 7 representative previous days of insulin therapy at week 4 10. Total insulin delivery measured using insulin records of 7 representative previous days of insulin therapy at week 4 11. Total number of hours and percentage of time of sensor availability |
| Overall study start date | 15/12/2020 |
| Overall study end date | 15/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 126 (84 commercial AID and 42 DIYAID users) |
| Total final enrolment | 78 |
| Participant inclusion criteria | 1. Males and females ≥18 years old 2. Clinical diagnosis of type 1 diabetes for at least 1 year (The diagnosis of type 1 diabetes is based on the investigator’s judgment; C-peptide level and antibody determinations are not needed) 3. Having been on AID therapy for at least 3 months 4. Willing to carry an additional CGM and a receiver for 30 days to collect blinded CGM data 5. Accepting that their pump setting parameters to be collected by the research team. This access will be limited to the study period |
| Participant exclusion criteria | 1. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R) 2. Clinically significant nephropathy (eGFR <15 ml/min/1.73m², planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator 3. Recent (<6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery) 4. Anticipated therapeutic change (including change of insulin, CGM sensor or AID system type) between admission and end of the study 5. Anticipated need to use acetaminophen during the study period 6. Pregnancy (ongoing or current attempt to become pregnant) 7. Breastfeeding 8. Plan to go abroad in a foreign country during the study period 9. Severe hypoglycemic episode within two weeks of screening 10. Severe hyperglycemic episode requiring hospitalization in the last 3 months 11. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) 12. Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study. 13. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed 14. Known or suspected allergy to the study products (e.g., Dexcom adhesive) 15. Other serious medical illness likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator 16. Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change) 17. Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI) 18. In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device |
| Recruitment start date | 31/03/2021 |
| Recruitment end date | 10/01/2023 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal
H2W 1R7
Canada
Sponsor information
Research organisation
110, avenue des Pins Ouest
Montreal
H2W 1R7
Canada
| Phone | 514 987-5500 |
|---|---|
| info@ircm.qc.ca | |
| Website | https://ircm.qc.ca/en |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at the Montreal Clinical Research Institute. With the participant’s written consent, the data collected during this study will also be added to the PROMD biobank. All the datasets generated during and/or analysed during this study will remain confidential to the extent provided by law. Participants will only be identified by a code number. The key to the code linking participants to their data will be kept by the researcher responsible for this study. The researcher responsible for this study could forward your coded data to the DIYAID community for the purpose of improving algorithms. The researcher responsible for this study could also forward your coded data to healthcare authorities (e.g., Health Canada) for the purpose of assessing the benefits and limitations of different AID systems. However, the researcher responsible and any entities who receive the research data will respect the confidentiality rules in effect in Quebec and Canada regardless of the country to which your data may be transferred. The study data will be stored for at least 25 years by the researcher responsible for this study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/03/2025 | 22/04/2025 | Yes | No |
Editorial Notes
22/04/2025: Publication reference and total final enrolment added.
22/01/2024: The intention to publish date was changed from 30/07/2023 to 31/12/2024.
25/01/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/03/2023 to 15/01/2023.
2. The recruitment end date was changed from 20/03/2023 to 10/01/2023.
3. The intention to publish date was changed from 30/10/2023 to 30/07/2023.
15/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 20/03/2022 to 20/03/2023.
2. The overall trial end date was changed from 30/03/2022 to 30/03/2023.
3. The intention to publish date was changed from 30/05/2022 to 30/10/2023.
28/09/2021: The target number of participants was changed from '126' to '126 (84 commercial AID and 42 DIYAID users)'.
15/03/2021: Trial's existence confirmed by Instituit de Recherches Cliniques de Montreal
