Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02179281
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Medtronic MiniMed™ 640G system Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Medtronic MiniMed™ 640G Sensor Augmented Insulin Pump in Children - The SportGuard Study
Study Start Date : October 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: Suspend Before Low feature turned ON

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
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.

Active Comparator: Suspend Before Low feature turned OFF

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
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.




Primary Outcome Measures :
  1. Significant between-group difference in number of hypoglycemic events [ Time Frame: After all patients completed 14 days of study treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179281


Locations
Layout table for location information
Israel
Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes
Petah Tikva, Israel, 4920235
Slovenia
University of Ljubljana, Faculty of Medicine
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Tadej Battelino, PhD University of Ljubljana, Faculty of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT02179281    
Other Study ID Numbers: SG-01
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases