Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems — SAFEDRIVE  

Type 1 Diabetes Mellitus Clinical Trial

Official title: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study

Status Not yet recruiting

Clinical Trial Summary

The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy

Clinical Trial Description

Study Aim The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy. The main goal is to verify the safety of the closed-loop during vehicle driving. Methods/design Ethical approval The protocol will be approved by the multicentric Ethics committee of the Motol University. All the participants will sign the informed consent. Definitions Hypoglycemia: a glucose value of 3.9 mmol/L (70 mg/dL) or less Severe hypoglycemia: any hypoglycemia requiring external assistance for recovery Design This is a national multi-centre prospective observational controlled study that focuses on the safety of the insulin pump closed-loop during the vehicle driving A total of 100 patients will be enrolled in the study group and 20 patients in the control group at 10-20 study centres. Main study group : patients with insulin pump MiniMed 780 G + CGM Control group: patients treated by multiple daily injection (MDI) + CGM Duration of the study for an individual subject (CGM measurement and completion of the questionnaire) will be 10 days. Centres and patient selection Patients are recruited through 10-20 centres in the Czech Republic. Centres will be selected based on outpatient diabetologists who have experience with insulin pump closed-loop insulin treatment, respecting the distribution in all the regions of the Czech Republic to achieve the reasonable representativeness. Inclusion and exclusion criteria The inclusion criteria for the main (active) arm are: type 1 diabetes, patient aged ≥18 years, diabetes duration ≥3 years, regularly driving (non-professional drivers only), treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment, willingness to fill in the study questionnaires, and a signed patient's informed consent form. For the control arm, the therapy inclusion criterion will be treatment with multiple daily injection (MDI) insulin therapy and the use of CGM for at least 6 month, the other criteria are identical. The exclusion criteria are professional drivers, pregnancy, inability to be present at the follow-up visit, inability to complete the study questionnaires, and participation in another clinical study within the last 3 months. Study procedures Visit 1 During the V1, the physician will evaluate the inclusion and exclusion criteria. The physician will ask the patient whether he/she is willing to participate in the project and will make the patient sign the informed consent form. Patients included in the study will receive the hypo questionnaire and the Patient Diary from the physician. The questionnaire will be filled in by the patients during the V1, while the Patient Diary will be completed during a study period between the V1 and V2, the exact dates of the study period's beginnings and ends will be determined. The data reported by the physician during visit 1 are summarised in Table 1. Table 1: Data obtained by the physician during visit 1 (V1): Inclusion / exclusion criteria Age Gender Height Body weight BMI Smoking history sBP (systolic blood pressure), dBP (diastolic blood pressure), heart rate Personal medical history Current and past history of diabetes, complications of diabetes Concomitantly used medicines HbA1c level Type of driving licence, type of vehicle, frequency of driving Hypoglycemia questionnaire: frequency of hypoglycemia within last 6 months, symptoms, typical occasions/causes, usual treatment, Gold/Clark score CGM records available within the last 6 month Study period (contiguous 10 days) Each patient completes the Patient Diary during the study period of 10 days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study) - see the diary in the attachment. Visit 2 A V2 will take place as soon as possible after the study period is completed but not later than ~2 weeks after the V1. During this visit, the patient will deliver his/her completed the Patient Diary. The CGM data from the period between V1 and the end of the study period will be downloaded. Outcomes Primary outcome The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods. Secondary outcomes - Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period). - The mean glycemia, glycemia variability (SD) during the periods of driving compared with the rest of the day. - Mean glycemic trajectory during the driving (in the time since driving commencement). - Number of alarms issued by the pump during the period of driving. - Insulin and food management before a and during the periods of driving - Insulin delivery data (number of correction boluses, basal changes during the period of driving. - comparison of daily average glycemia before the study and during the study to check (and statistically correct) for the possible effect of "being under surveillance" upon the study results. - comparison of the daily frequency of hypoglycemia before the study and during the study - Analysis of data related to the other part of the study (periods of night sleep, periods of occupation, periods of physical activity, periods of stress). Data confidentiality The information about participants will be stored anonymously under the identification number (ID) issued by investigators at the beginning of the study. During the study procedures and data analysis, participants will only be able to be identified by their ID number so as to assure their privacy and confidentiality. The centre investigators will not analyze the obtained data (CGM record and patient diary), those will be sent to the study's principal investigator. The study's principal investigator will collect the anonymized participants´ data from all the centres and will not participate in participant recruitment to avoid the possibility to disrupt a patient's anonymity. The study data will be kept strictly confidential on password-protected computers in the research team's offices, which will be accessible only by the research team members. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Drive
• Hypoglycemia
• Type 1 Diabetes Mellitus
• Type 1 Diabetes Mellitus With Hypoglycemia

• NCT number: NCT06382350
• Study type: Observational
• Source: University Hospital, Motol
• Contact: Eva Al Jamal, Mgr.
• Phone: 224 431 017
• Email: eva.aljamal@fnmotol.cz
• Status: Not yet recruiting
• Start date: April 2024
• Completion date: May 2026