Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)

Type 1 Diabetes Clinical Trial

Official title:

Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295788
• Other study ID #: CHEO 09/05E
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2021
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. This randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

Description:

REAL-Time Continuous Glucose Monitoring (RT-CGM) improves diabetes control in adults with type 1 diabetes. However, studies of RT-CGM in children and adolescents have been mostly negative. The lack of effectiveness in the pediatric population appears directly related to adherence to RT-CGM, i.e., the willingness of children and teens to wear and use this technology. Most previous RT-CGM studies have focused on experienced pump users or children with new-onset diabetes. At the time of pump initiation, children and adolescents who have been living with diabetes (and their parents) are highly motivated to make changes in their diabetes management and to take on additional responsibilities to improve their diabetes control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric population. The investigators hypothesize that readiness for making changes in diabetes management will be greater at the time of pump initiation than at six months after the pump start. Further, the investigators hypothesize that readiness for change at the time of RT-CGM initiation will predict future adherence to RT-CGM and its effectiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2017
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion criteria:

• Males and females age 5-18 years old.

• Established T1D diagnosis for a minimum of one year.

• Naïve to CSII therapy and ready to start CSII with the Veo pump (Medtronic) .

• Willing to use RT-CGM and to be randomly assigned to either simultaneous or delayed RT-CGM initiation.

• Regular diabetes follow up at one of the 5 participating sites.

• Internet access at home (to upload RT-CGM data).

• Parent(s) or legally acceptable representative able to speak and read English or French.

• Ability of the subject and parent(s) or legally acceptable representative to participate in all aspects of this clinical trial.

• Written informed consent must be obtained and documented, with assent of the child if <14 years of age.

Exclusion Criteria

• Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.

• Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject.

• Prior use of RT-CGM for more than 50% of the time over the past 6 months.

• Prior enrollment in the current study.

• Current enrollment in another intervention trial.

Related Conditions & MeSH terms

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

Intervention

Device:
• Simultaneous RT-CGM and Pump Initiation
Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.
• Delayed Initiation of RT-CGM
Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Markham-Stouffville Hospital	Markham	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario	Canadian Clinical Trial Network, Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Lawson ML, Verbeeten KC, Courtney JM, Bradley BJ, McAssey K, Clarson C, Kirsch S, Curtis JR, Mahmud FH, Richardson C, Cooper T, Chan J, Tang K. Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial. Pediatr Diabetes. 2021 Mar;22(2):279-287. d — View Citation

Verbeeten KC, Perez Trejo ME, Tang K, Chan J, Courtney JM, Bradley BJ, McAssey K, Clarson C, Kirsch S, Curtis JR, Mahmud FH, Richardson C, Cooper T, Lawson ML; CGM TIME Trial Study Group and the JDRF Canadian Clinical Trials Group. Fear of hypoglycemia in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to CGM (hours per week)	Number of hours of RT-CGM use per week	one year
Secondary	A1C	Hemoglobin A1C	one year
Secondary	Readiness for change	SOCRATES - Diabetes Version	six months
Secondary	Treatment Satisfaction and Quality of Life	Insulin Delivery Systems Rating Questionnaire (IDSRQ)	one year
Secondary	Fear of Hypoglycemia	Hypoglycemia Fear Scale (HFS-98)	one year
Secondary	Barriers to Adherence	Modified Barriers to Adherence Questionnaire (MBAQ)	one year
Secondary	Perception of Barriers/Facilitators to RT-CGM Use	CGM Satisfaction Scale (CGM-SAT)	one year

External Links

•   JDRF Canadian Clinical Trial Network