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

Type 1 Diabetes Mellitus Clinical Trial

— SportGuard  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179281
• Other study ID #: SG-01
• Status: Completed
• Phase: N/A
• First received: June 28, 2014
• Last updated: March 9, 2015
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Slovenian Agency for Drugs and Medical DevicesIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes	Petah Tikva
Slovenia	University of Ljubljana, Faculty of Medicine	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Countries where clinical trial is conducted

Israel,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant between-group difference in number of hypoglycemic events		After all patients completed 14 days of study treatment	No