The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

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

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Recruitment Status

COMPLETED

Total Enrollment

339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-30

Brief Summary

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The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.

The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

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Detailed Description

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Conditions

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Type 1 Diabetes Continuous Glucose Monitoring Children Glucose Variability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CGM

CGM users

No interventions assigned to this group

SMBG

Non-CGM users

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age below 7 years of age (at inclusion)
2. Type 1 diabetes for at least 6 months
3. Insulin pump user for at least 3 months
4. Treated with rapid or ultra-rapid acting insulin analogue

Exclusion Criteria

1. Physical or psychological disease likely to interfere with normal conduct of the study
2. Untreated coeliac disease or thyroid disease
3. Current treatment with drugs known to interfere with glucose metabolism
4. Subject/carer's severe visual impairment
5. Subject/carer's severe hearing impairment

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No