Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children

Study Overview
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Brief Summary
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The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed system significantly reduces hypoglycemic excursions and thus provide proactive protection to the user.

Detailed Description
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This is randomized two-arm parallel controlled open label study that will be conducted at two sites, in Slovenia and Israel. It is an investigator initiated pediatric clinical study. Study will be conducted on pediatric population during two weeks, following a 3 day Run-in period that will allow the patients to get familiar with study device and CGM (SmartGuard OFF). Patients will be asked to continuously wear the study device for 14 days, which will be set up by study staff according to randomization in the specific group. They will be provided with a diary for entering their daily activity, food consumption (carb count) and eventual adverse events.

Official Title
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Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Medtronic MiniMed™ 640G Sensor Augmented Insulin Pump in Children - The SportGuard Study

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Medtronic MiniMed™ 640G system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry Diagnosed with Type 1 DM at least 12 months prior to signature of Patient Informed Consent (PIC). Age between 8-18 years old (inclusive) at signature of PIC Treated by CSII with or without CGM at least 3 months prior to signature of PIC, but no use of LGS for last two weeks prior to signature of PIC. HbA1c value at screening visit ≤10% Knowledgeable on the use of CSII, administering treatment, adjusting insulin according to diet and exercise Performance of an average of four (4) SMBG per day, as evidenced from patient files, or latest insulin pump or glucose meter download Treated by the investigator's centre for at least 6 months prior signature of PIC. Willing to undergo all study procedures Exclusion Criteria: Hearing or vision impairment so that glucose display and alarms cannot be recognized. Alcohol or drug abuse. Non-compliance with diabetes self-monitoring and disease management Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.). Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g. chronic corticosteroid therapy), Eating disorders and morbid obesity (defined as adults: BMI>35 and children BMI > 2 SD for age) as assessed by the investigator. Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures. Patient that does not have a reliable support person. Participation in another clinical study, on-going or completed less than 2 months prior to signature of PIC. Pregnancy (per investigator judgment, including pregnancy test if necessary)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspend Before Low feature turned ON<br>MiniMed™ 640G system with the Suspend Before Low feature turned ON; continuously set on at 3,6 mmol/L (65 mg/dL). Suspend On Low Alert and Resume Basal Alert for the SmartGuard group should be set OFF. Administered intervention: Medtronic MiniMed™ 640G system | Device: Medtronic MiniMed™ 640G system<br>* The MiniMed™ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes.<br>|
| Active Comparator: Suspend Before Low feature turned OFF<br>MiniMed™ 640G system with the Suspend Before Low and Suspend On Low features are both turned OFF; Alert On Low is set at 65 mg/dL (3,6 mmol/L). Resume Basal Alert should be set OFF as well. Administered intervention: Medtronic MiniMed™ 640G system | Device: Medtronic MiniMed™ 640G system<br>* The MiniMed™ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant between-group difference in number of hypoglycemic events |  | After all patients completed 14 days of study treatment |