Phase 3
Completed N=146
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00760526 ↗
Enrolled (actual)
146
Serious AEs
8.2%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events — 13; 19 participants
Summary
The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events |
13; 19 | — |
| SECONDARY Number of Severe Hypoglycemic Events Experienced by Participants |
3; 6 | — |
| SECONDARY CGM Glucose Values (mg/dL) |
48; 49 | — |
| SECONDARY Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) |
1.5; 2.1 | — |
| SECONDARY Measures of Variability: Standard Deviation (SD) |
73; 81 | — |
| SECONDARY Measures of Variability: Mean Absolute Rate of Change |
0.91; 0.90 | — |
| SECONDARY Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) |
144; 145 | — |
| SECONDARY Parental Quality of Life Measures: Hypoglycemia Fear Survey |
38; 42 | — |
| SECONDARY Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) |
44; 49 | — |
| SECONDARY Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale |
2.7; 2.4 | — |
| SECONDARY Parental Quality of Life Measures: CGM Satisfaction Scale |
3.9 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
- Age >4.0 to = 7.0%
- Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)
Exclusion Criteria
- Diabetes diagnosed <6 months of age
- Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:
- Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
- Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
- Home use of CGM in past 6 months.
- Participation in an intervention study (including psychological studies) in past 6 weeks.
- Another member of the same household is participating in this study.
Data sourced from ClinicalTrials.gov (NCT00760526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.