Evaluation of Minimed 670G in T1D Patients on Multiple Daily Injection
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Introduction. Sensor Augmented Pump has demonstrated superiority over insulin pump and
      Multiple Daily Injection (MDI) in achieving optimal glucose control and can improve quality
      of life in Type 1 Diabetes (T1D) patients. Hybrid closed loop (HCL) insulin pump Minimed 670G
      is a FDA approved device and European Conformity (CE) mark with SmartGuard technology and
      closed loop algorithm, which will allow the patients to improve their diabetes management.
      Hybrid closed loop insulin pump Minimed 670G monitors glucose in the subcutaneous tissues and
      automatically adjusts the delivery of rapid acting insulin as basal rate based on the user's
      glucose reading. SmartGuard technology in insulin pump, based on user's sensor glucose values
      can predict when glucose is approaching low levels, 30 minutes in advance and automatically
      stop insulin delivery. When user's glucose levels recover, SmartGuard will automatically
      resume insulin delivery. CareLink is personal software, which downloads the data from insulin
      pump, glucose sensor and glucometer to visualize diabetes information with charts, statistics
      and events that help patient and health provider to identify and understand patterns and
      trends The objective of this study is to assess structured group education on boarding
      protocol of the HCL Minimed 670 G in achieving glucose control of patients on MDI.

      Methods. This study is a single-arm, single-center, clinical investigation in subjects with
      type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 30
      subjects (age 6 - 17) will be enrolled in order to reach 26 subjects who will complete the
      HCL study. The investigators will start the clinical process for initiating an insulin pump,
      which is typically done with pre-pump classes. HbA1c, derived from CGM will be performed at
      baseline and 3 months during the study. The following parameters will be analyzed: % patients
      achieving Time in Range (TIR) > 67% from 70 mg/dl to 180 mg/dl; % patients achieving TIR <3%,
      below time in range (<70 mg/dl) and % patients achieving both TIR > 67% and <3% time below
      Range. Collection of demographics and medical history, data for diabetes devices (eg meters,
      sensors, pumps) and brief clinical physical exam including vital signs and skin assessment
      will be obtained via Hospital Electronic Medical File (Cerner Millennium, North Kansas City,
      US) and will be kept as electronic data on a separate research server.
    

Detailed description: 
      This study is a single-arm, single-center, clinical investigation in subjects with Type 1
      Diabetes (T1D) on Hybrid Closed Loop (HCL) insulin pump Minimed 670G in a period of 3 months.
      A total of 30 subjects (age 6 - 17) will be enrolled in order to reach 26 subjects who will
      complete the HCL study.

      After reviewing the patient's eligibility and interest, the investigators will obtain
      informed consent and assent as appropriate. The investigators will start the clinical process
      for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived
      from Continuous Glucose Monitoring (CGM) device will be analyzed at baseline and 3 months
      during the study.

      Collection of demographics and medical history, data for diabetes devices (eg meters,
      sensors, pumps) and brief clinical physical exam including vital signs and skin assessment
      will be obtained via Hospital Electronic Medical File (Cerner Millennium, North Kansas City)
      and will be kept as electronic data on a separate research server.

      Base line assessment

      The main variables checked at baseline:

        -  Age

        -  Duration of diabetes

        -  Total daily insulin (TDI) dose

        -  HbA1c, derived from CGM device

      Recruitment process All patients will be recruited during the regular clinic visits at
      Diabetes Clinics at Sidra Medicine in Doha. The Principal investigator will evaluate the
      patient if meets the inclusion criteria during the regular clinic visits. A research
      assistant will take patient and family in other room to explain the study protocol and give
      patient information. Parents and patients can ask questions about the study. After the
      explanation of the study protocol, if parents and child agree to participate, they can sign
      the documents for including in the study. Parents can also take the documents home to
      consider the possible inclusion in the study. They can also talk to principal investigator
      before including the child in the study. If parents agree to be a part of the study, they can
      call research assistant to include the child in the study. The research assistant will
      arrange a separate meeting to start the process.

      Run in period The 2-week run-in period will be used for education and training for the new
      devices.

      Week 1: Pump school (Sunday to Thursday) A group session of 2-3 patients/families will be
      performed to allow subject to become familiar with new insulin pump. Five sessions in a row
      (each two hours) will be performed during a week.

      Glucose sensor (Suspend before low and suspend on low will be off) will be started on the
      first day (Same protocol which is currently used in Sidra Medicine).

      Topics and education Sunday: Basal Bolus Concept; Operational modes of the pump;
      Understanding the pump; Pump buttons; Glucose readings; Reading the display; Sensor alerts
      and alarms; How to insert a sensor; Pump menus Monday: Carelink personal; Battery change;
      Setting date and time; Basal rates; Pump suspend; Bolus wizard, Bayer Contour Next Link 2.4
      Tuesday: Infusion set change; Alarms and alerts; Suspend before low and Suspend of low;
      Advanced carbs counting Wednesday: Temporary basal; Emergency kit; Low blood sugar; High
      Blood Sugar; Sick day's management for pump; Diabetic Ketoacidosis (DKA)' Blood glucose Blood
      ketones; Exercise; Travel Thursday: Auto Mode; Using Auto Mode for the first time Checking
      Auto Mode Readiness; sensor graph in Auto Mode' Using pump in Auto Mode; Entering a Blood
      Glucose value in Auto Mode; Suspending and Resuming Delivery in Auto Mode Evaluation Check
      List; Pump Care; Setting the pump; Sensor start by patient The sensor will be started the
      first day for teaching and observational purposes only. CareLink account creation and sharing
      of access is mandatory in the first week.

      Week 2: Pump start (Sunday to Sunday) Sensor Augmented Pump will be initiated with both Smart
      Guard and HCL turned off, to allow the investigators, subjects and device to get more
      information before starting the HCL. This week will be used as a warm up period for Auto
      Mode.

      Study Period 3 Months Following the two week run-in period using the Minimed 670G, Auto Mode
      will be activated and all subjects will participate in a 3-month study period.

      The patient/family will upload data into the CareLink system and the data will be reviewed by
      a member of the clinical team. Adjustments to system settings will be suggested to the family
      as clinically appropriate.

      Visit 1- Day 1 In-Clinic visit. Insulin pump will be started in Auto mode. Carelink download
      for initial pump settings. HbA1c will be obtained.

      Visit 2- Day 3 Remote visit. Download pump at home, phone call to patient. Check the Auto
      Mode, pump settings and fine tune.

      Visit 3- Day 7 In-Clinic visit. Download pump. Check the Auto Mode, pump settings and fine
      tune. Visit 4- Day 14 Remote visit. Download pump at home, phone call the patient. Check the
      Auto Mode, pump settings and fine tune.

      Visit 5- Day 28 In-Clinic visit. Month 1 Download pump. Check the Auto Mode, pump settings
      and fine tune. Visit 6- Day 42 Remote visit. Download pump at home, phone call to patient.
      Check the Auto Mode, pump settings and fine tune.

      Visit 7- Day 84 In-Clinic visit. Month 3 Download pump. HbA1c will be obtained.

      Data Analysis The analysis of the main endpoint 3 month Time in Range, post intervention will
      be tested by the paired student t-test or paired Wilcoxon test, in case of non-normality of
      the end point. Evident outliers will be excluded from the main analysis but data on the
      complete analysis will be provided as well.

      The different continuous baseline values will be checked for normality of distribution using
      the mean-median comparison, skewness and kurtosis (-3 to +3), spread, Kolmogorov-Smirnow and
      Shapiro-Wild tests, outliers, histograms and Q-Q-plots.
    

Intervention name(s): Hybrid Closed Loop Insulin Pump Minimed 670G
Intervention type(s): Device
Intervention description(s): Five Day Group Education on Minimed 670G
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Type 1 Diabetes on Multiple Daily Injections, motivated and willing to switch
        Hybrid Closed Loop Minimed 670G.
      
Keywords: Diabetes Mellitus Type 1; Insulin Pump; Hybrid closed Loop System; Minimed 670G