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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Medtronic MiniMed™ 640G system

About this trial

This is an interventional prevention trial for Type 1 Diabetes Mellitus

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes
University of Ljubljana, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suspend Before Low feature turned ON

Suspend Before Low feature turned OFF

Arm Description

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

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

Outcomes

Primary Outcome Measures

Significant between-group difference in number of hypoglycemic events

Secondary Outcome Measures

Full Information

NCT ID

NCT02179281

First Posted

June 28, 2014

Last Updated

March 9, 2015

Sponsor

University of Ljubljana, Faculty of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02179281

Brief Title

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

Acronym

SportGuard

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Ljubljana, Faculty of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suspend Before Low feature turned ON

Arm Type

Experimental

Arm Description

Arm Title

Suspend Before Low feature turned OFF

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Medtronic MiniMed™ 640G system

Intervention Description

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 Measure Information:

Title

Significant between-group difference in number of hypoglycemic events

Time Frame

After all patients completed 14 days of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tadej Battelino, PhD

Organizational Affiliation

University of Ljubljana, Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schneider Children's Medical Center of Israel, The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes

City

Petah Tikva

ZIP/Postal Code

4920235

Country

Israel

Facility Name

University of Ljubljana, Faculty of Medicine

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

12. IPD Sharing Statement

Citations:

PubMed Identifier

28351897

Citation

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.

Results Reference

derived

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

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