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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Canadian Clinical Trial Network | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simultaneous RT-CGM and Pump Initiation | Experimental | The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy. |
|
| Delayed RT-CGM Initiation | Active Comparator | The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous RT-CGM and Pump Initiation | Device | Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to CGM (hours per week) | Number of hours of RT-CGM use per week | one year |
| Measure | Description | Time Frame |
|---|---|---|
| A1C | Hemoglobin A1C | one year |
| Readiness for change | SOCRATES - Diabetes Version | six months |
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Inclusion criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Margaret L Lawson, MD | Children's Hospital of Eastern Ontario | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Children's Hospital | Hamilton | Ontario | L8S 4J9 | Canada | ||
| Children's Hospital of Western Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33098212 | Result | 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. doi: 10.1111/pedi.13144. Epub 2020 Nov 4. | |
| 33179818 | Result |
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Simultaneous or Delayed initiation of continuous glucose monitoring
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|
| Delayed Initiation of RT-CGM | Device | Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy. |
|
| Treatment Satisfaction and Quality of Life | Insulin Delivery Systems Rating Questionnaire (IDSRQ) | one year |
| Fear of Hypoglycemia | Hypoglycemia Fear Scale (HFS-98) | one year |
| Barriers to Adherence | Modified Barriers to Adherence Questionnaire (MBAQ) | one year |
| Perception of Barriers/Facilitators to RT-CGM Use | CGM Satisfaction Scale (CGM-SAT) | one year |
| London |
| Ontario |
| N5Y 3T2 |
| Canada |
| Markham-Stouffville Hospital | Markham | Ontario | L3P 7P3 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| 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 children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial. Pediatr Diabetes. 2021 Mar;22(2):288-293. doi: 10.1111/pedi.13150. Epub 2020 Nov 27. |
| 25034216 | Derived | Lawson ML, Bradley B, McAssey K, Clarson C, Kirsch SE, Mahmud FH, Curtis JR, Richardson C, Courtney J, Cooper T, Downie CJ, Rajamannar G, Barrowman N; CGM TIME Trial Study Group; JDRF Canadian Clinical Trial Network CCTN1101. The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics. BMC Pediatr. 2014 Jul 18;14:183. doi: 10.1186/1471-2431-14-183. |
| 24876616 | Derived | Olivier P, Lawson ML, Huot C, Richardson C, Nakhla M, Romain J. Lessons learned from a pilot RCT of simultaneous versus delayed initiation of continuous glucose monitoring in children and adolescents with type 1 diabetes starting insulin pump therapy. J Diabetes Sci Technol. 2014 May;8(3):523-8. doi: 10.1177/1932296814524855. Epub 2014 Feb 27. |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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