Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children
SportGuard
1 other identifier
interventional
100
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 10, 2015
March 1, 2015
4 months
June 28, 2014
March 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Significant between-group difference in number of hypoglycemic events
After all patients completed 14 days of study treatment
Study Arms (2)
Suspend Before Low feature turned ON
EXPERIMENTALMiniMed™ 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
Suspend Before Low feature turned OFF
ACTIVE COMPARATORMiniMed™ 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes
Petah Tikva, 4920235, Israel
University of Ljubljana, Faculty of Medicine
Ljubljana, 1000, Slovenia
Related Publications (1)
Battelino T, Nimri R, Dovc K, Phillip M, Bratina N. Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in Children With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Jun;40(6):764-770. doi: 10.2337/dc16-2584. Epub 2017 Mar 28.
PMID: 28351897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tadej Battelino, PhD
University of Ljubljana, Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2014
First Posted
July 1, 2014
Study Start
October 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 10, 2015
Record last verified: 2015-03