Assessing the Impact of Control-IQ Technology

NCT04838561 | Completed

• 1 other identifier: 21/26X
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Diabetes Impact and Device Satisfaction scale

  Baseline and 16 weeks

• Hypoglycemia Fear Survey (child and parent version)

  Baseline and 16 weeks

• The World Health Organisation- Five Well-Being Index

  Baseline and 16 weeks

• % time in target range 3.9-10.0 mmol/L (overall, day,and night)

  0, 4, 8, 12, and 16 weeks

• % time below target range <3.0mmol/L (overall, day, and night)

  0, 4, 8, 12, and 16 weeks

Other Outcomes (2)

• Open-Ended Questionnaire

  16 weeks

• INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire (Baseline and Post Intervention)

  Baseline and 16 weeks

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and youth with T1D followed at CHEO will be invited to participate in the study.

You may qualify if:

• Diagnosis of T1D
• Age 6-18 years
• Currently using the Tandem t:slim X2 insulin pump with Dexcom G6 CGM, who are initiating Control-IQ

You may not qualify if:

• Patients under the age of 6 years of age
• Patients who are not English or French speaking
• Patients unwilling to provide consent (assent where applicable).

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Tandem Diabetes Care, Inc.: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

Related Publications (7)

• 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.

  PMID: 33155824 BACKGROUND

• 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.

  PMID: 31618560 BACKGROUND

• 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.

  PMID: 30159816 BACKGROUND

• Pinsker JE, Muller 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.

  PMID: 32846114 BACKGROUND

• 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.

  PMID: 30761592 BACKGROUND

• 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. doi: 10.2337/diacare.10.5.617.

  PMID: 3677982 BACKGROUND

• Zuijdwijk C, Courtney J, Mitsakakis N, Hayawi L, Sutherland S, Newhook D, Ahmet A, Goldbloom EB, Khatchadourian K, Lawrence S. Control-IQ Technology Positively Impacts Patient Reported Outcome Measures and Glycemic Control in Youth with Type 1 Diabetes in a Real-World Setting. Pediatr Diabetes. 2023 Apr 12;2023:5106107. doi: 10.1155/2023/5106107. eCollection 2023.

  PMID: 40303267 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Caroline Zuijdwijk, MD, FRCPC

  Children's Hopsital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endrocinologist, MD FRCPC

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 9, 2021
• Study Start: March 15, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)