Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics

NCT ID: NCT05969106

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rtCGM + MDI

Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI)

Tandem Control-IQ

Intervention Type DEVICE

AID-system

rtCGM + CSII

Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII)

Tandem Control-IQ

Intervention Type DEVICE

AID-system

Tandem Control-IQ

Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system

Tandem Control-IQ

Intervention Type DEVICE

AID-system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tandem Control-IQ

AID-system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 2-19 years at the start
* Diagnosed with Type 1 diabetes
* Min duration three months
* Willingness to participate in the study

Exclusion Criteria

* Pregnancy
* Unwillingness to share and upload CGM data
* Reluctance to come to visit and to follow protocol
* History of allergic reaction to Dexcom CGM materials or adhesives in contact with the skin.
* Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
Minimum Eligible Age

2 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Johan Peter Adolfsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Adolfsson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Västra Götalandsregionen, Gothenburg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The hospital of Halland Kungsbacka

Kungsbacka, Region of Halland, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VastraGotaland - 2022-00332-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.