Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT05969106
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2023-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
Official Title:
A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARCARE
Brief Summary:
To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.
Detailed Description:
In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the three modalities for at least six months were included in the analysis. Inclusion required all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. Comparisons were conducted regarding Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1 month before the study started until 18 months. Sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the Swedish Social Insurance Agency. Comparisons were then made between the three treatment alternatives.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: