Type 1 Diabetes Clinical Trial
Official title:
Assessing the Impact of Control-IQ Technology on Quality of Life and Glycemic Control in Children and Youth With Type 1 Diabetes in a Canadian Context
NCT number | NCT04838561 |
Other study ID # | 21/26X |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2021 |
Est. completion date | October 26, 2021 |
Verified date | January 2022 |
Source | Children's Hospital of Eastern Ontario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump. Primary Objective: To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life.
Status | Completed |
Enrollment | 65 |
Est. completion date | October 26, 2021 |
Est. primary completion date | October 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of T1D 2. Age 6-18 years 3. Currently using the Tandem t:slim X2 insulin pump with Dexcom G6 CGM, who are initiating Control-IQ Exclusion Criteria: 1. Patients under the age of 6 years of age 2. Patients who are not English or French speaking 3. Patients unwilling to provide consent (assent where applicable). |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario | Tandem Diabetes Care, Inc. |
Canada,
Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16. — View Citation
Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987 Sep-Oct;10(5):617-21. — View Citation
Dadlani V, Pinsker JE, Dassau E, Kudva YC. Advances in Closed-Loop Insulin Delivery Systems in Patients with Type 1 Diabetes. Curr Diab Rep. 2018 Aug 29;18(10):88. doi: 10.1007/s11892-018-1051-z. Review. — View Citation
O'Malley G, Messer LH, Levy CJ, Pinsker JE, Forlenza GP, Isganaitis E, Kudva YC, Ekhlaspour L, Raghinaru D, Lum J, Brown SA; iDCL Trial Research Group. Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial. Diabetes Technol Ther. 2021 Apr;23(4):245-252. doi: 10.1089/dia.2020.0472. — View Citation
Pinsker JE, Müller L, Constantin A, Leas S, Manning M, McElwee Malloy M, Singh H, Habif S. Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology. Diabetes Technol Ther. 2021 Feb;23(2):120-127. doi: 10.1089/dia.2020.0388. Epub 2020 Sep 10. — View Citation
Weissberg-Benchell J, Shapiro JB, Hood K, Laffel LM, Naranjo D, Miller K, Barnard K. Assessing patient-reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures. Diabet Med. 2019 May;36(5):644-652. doi: 10.1111/dme.13930. Epub 2019 Mar 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Open-Ended Questionnaire | Explores the effect of Control-IQ technology on patient and parents' sleep, school, activities/ sports, mood and family dynamics | 16 weeks | |
Other | INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire (Baseline and Post Intervention) | To explore whether or not youth and parents' expectations of Control-IQ align with their experience of using this this automated insulin delivery system (by comparing the INSPIRE Questionnaire baseline and post-assessment scores)
Score 0-100- mean score is significantly larger than 60 (out of 100). A score of greater than 60 indicates a perceived benefit of Control-IQ on psychosocial functioning and quality of life. Mean baseline INPSIRE score will be compared to the mean post-assessment INSPIRE score to assess if expectations of Control-IQ align with the experience of using this automated insulin delivery system. |
Baseline and 16 weeks | |
Primary | INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire Post Intervention (Youth and Parent Versions) | Measures perceptions of the impact of automated insulin delivery systems on users' psychosocial functioning and quality of life.
Score 0-100- mean score is significantly larger than 60 (out of 100). A score of greater than 60 indicates a perceived benefit of Control-IQ on psychosocial functioning and quality of life. |
16 weeks | |
Secondary | Change in Diabetes Impact and Device Satisfaction scale | Evaluates users' experience interacting with their insulin delivery device, and the impact of diabetes on their life on a 10-point Likert Scale. Scoring: Device Satisfaction average of items 1-7 (#5, #7 are reverse scored), Diabetes Impact: Average of items 8-11. Higher Score Indicates increased device satisfaction. | Baseline and 16 weeks | |
Secondary | Hypoglycemia Fear Survey (child and parent version) | Assess change in fear of hypoglycemia among children with type 1 diabetes and parents of children with type 1 diabetes.
Mean score will be compared pre and post study Behaviour (score 0-40) - lower score better (less behaviours associated with fear of hypo) Worry (score 0-60) - lower score better (less worry re: hypoglycemia) |
Baseline and 16 weeks | |
Secondary | The World Health Organisation- Five Well-Being Index | Assessing change in subjective psychological well-being in research and clinical settings.
The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks). All of the time = 5 Most of the time = 4 More than half of the time = 3 Less than half of the time = 2 Some of the time = 1 At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. |
Baseline and 16 weeks | |
Secondary | % time in target range 3.9-10.0 mmol/L (overall, day,and night) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. | 0, 4, 8, 12, and 16 weeks | |
Secondary | % time below target range <3.0mmol/L (overall, day, and night) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. | 0, 4, 8, 12, and 16 weeks | |
Secondary | % time below target range <3.9mmol/L (overall, day, and night) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. | 0, 4, 8, 12, and 16 weeks | |
Secondary | % time above target range >10mmol/L (overall, day, and night) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame.. | 0, 4, 8, 12, and 16 weeks | |
Secondary | % time above target range >13.9mmol/L (overall, day, and night) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. | 0, 4, 8, 12, and 16 weeks | |
Secondary | Average glucose and standard deviation (mmol/L) | Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. | 0, 4, 8, 12, and 16 weeks | |
Secondary | Coefficient of variation (%) | Measure of glycemic control will be collected from the Dexcom Clarity Platform. | 0, 4, 8, 12, and 16 weeks | |
Secondary | Estimated HbA1c (%) | Will be collected from the Dexcom Clarity Platform. | 0, 4, 8, 12, and 16 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 | |
Completed |
NCT02750527 -
Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany
|