Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the Extended Mio 30 infusion set (EM30IS) 7-day functioning compared to the regular Mio 30 infusion set (M30IS) 3-day functioning. The study will be carried out in adult patients with type 1 diabetes. Secondary objective, to evaluate the differences in glucose control between the infusion set currently used by participants (Medtronic Quick set infusion sets) and the Medtronic Mio 30 Infusion Set.


Clinical Trial Description

This is a 1-center, prospective, open-label, cross-over controlled study with type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 40 subjects will be enrolled in order to have 20 subjects meeting eligibility criteria. Eligible patients meeting the enrollment and randomization criteria will enter a run-in period of up to 1 month for device adaptation. After the run- in phase, The participants will enter the first study part; participants will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for 1 month. The order will be determined by the randomization process: Arm A: Quick set infusion set- M30IS. First phase Quick set, second phase Mio 30. Arm B: M30IS- Quick set infusion set. First phase Mio 30, second phase Quick set infusion set. Trial Arm A: Subjects will be randomized to a group who will be using the Quick set infusion set for the initial Phase. All patients will be trained on the use of the Quick set infusion set by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another Quick set infusion set). After 1 month, the patients will return to a visit, return all the extracted catheters sets and will switch to the M30IS, entering Phase 2. All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another M30IS). 1 month, the patients will return all the extracted catheters sets. Trial Arm B: Subjects will be randomized to a group who will be using the Mio 30 infusion set (M30IS) for the second Phase. All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another M30IS). After 1 month, the patients will return to a visit, return all the extracted catheters sets and will switch to the Quick set infusion set, entering Phase 2. All patients will be trained at this visit on the use of the Quick set infusion set by site staff and demonstrate proficiency in the use of the Quick set infusion set. All subjects will be instructed to change sets every 3 days or at set failure (replace with another Quick set infusion set). 1 month, the patients will return all the extracted catheters sets After completing the first study part, participants will be randomized again into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for 4 sets (up to 28 days). The order will be determined by the randomization process: - Arm A: M30IS - EM30IS. First phase Mio 30, second phase Extended Mio 30. - Arm B: EM30IS - M30IS. First phase Extended Mio 30, second phase Mio 30. Trial Arm A: Subjects will be randomized to a group who will be using the Mio 30 infusion set (M30IS) for the Phase 1. All patients will be retrained on the use of the M30IS by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another M30IS). At day 12 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the Extended Mio 30 infusion set (EM30IS), entering Phase 2. All patients will be trained at this visit on the use of the EM30IS by site staff and demonstrate proficiency in the use of the EM30IS. All subjects will be instructed to change sets every 7 days or at set failure (replace with another EM30IS). After 28 days or after using 4 sets, the patients will return all the extracted catheters sets. Trial Arm B: Subjects will be randomized to a group who will be using the EM30IS for the initial Phase. All patients will be trained on the use of the EM30IS by site staff and will be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7 days or at set failure (replace with another EM30IS). At day 28 or after using 4 sets (set used defined as a set that was used for more than 6 hours), the patients will return to a visit, return all the extracted catheters sets and will switch to the M30IS, entering Phase 2. All patients will then be retrained on the use of the M30IS by site staff and demonstrate proficiency. All subjects will be instructed to change sets every 3 days or at set failure (replace with another M30IS). After 12 days or after using 4 sets, the patients will all the extracted catheters sets. Each subject will wear MiniMedâ„¢ 780G/670G insulin system. Each subject will be given for the first study part: 11 infusion sets each to wear, each infusion set for at least the labelled use time (3 days for M30IS or 3 days for Quick set infusin set), or until infusion set failure if this occurs before 3 days.for the second part 4 infusion sets each to wear, each infusion set for at least the labelled use time (3 days for M30IS or 7 days for EM30IS), or until infusion set failure if this occurs before 3 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05544643
Study type Interventional
Source Sheba Medical Center
Contact
Status Completed
Phase N/A
Start date August 4, 2022
Completion date August 4, 2022

See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A