Type 1 Diabetes Mellitus
Conditions
Brief summary
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
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.
Interventions
DEVICEMedtronic MiniMed™ 640G system
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.
Sponsors
University of Ljubljana, Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant between-group difference in number of hypoglycemic events | After all patients completed 14 days of study treatment |
Countries
Israel, Slovenia
Outcome results
None listed