N/A
Completed N=120
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
Source: ClinicalTrials.gov NCT02734667 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: Time Spent in Blood Glucose Range (70-180mg/dL) — 64.99; 62.54 percentage of time — p=0.64
Summary
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D). The investigators hope to learn about how continuous glucose monitoring affects glycemic variables and diabetes-related distress.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Spent in Blood Glucose Range (70-180mg/dL) |
64.99; 62.54 | 0.64 |
| PRIMARY Glucose Monitoring Satisfaction Survey (GMSS) - Parent |
3.52; 3.54; 3.76; 3.82; 3.65; 3.28 | 0.013 sig |
| PRIMARY Time Spent in Hypoglycemia (< 70 mg/dL) |
1.87; 5.06 | 0.003 sig |
| SECONDARY Pediatric Quality of Life Inventory |
75.38; 85.23; 82.67; 92.08; 75.27; 81.05 | — |
| SECONDARY Problem Areas in Diabetes Score |
1.02; 0.78; 0.77; 0.43; 1.84; 2.11 | — |
| SECONDARY Diabetes Distress Scale |
1.87; 1.85; 1.85; 1.52; 1.19; 1.3 | — |
| SECONDARY Patient Health Questionnaire 9 |
6.22; 9.22; 4.53; 3.71 | — |
| SECONDARY State-Trait Anxiety Inventory |
44.34; 49.71; 39.39; 34.05 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
7.04; 7.57; 6.1; 5.56 | — |
| SECONDARY Hypoglycemic Fear Survey |
23.67; 23.86; 21.45; 19.62 | — |
| SECONDARY Hypoglycemic Confidence Questionnaire |
23.65; 21.18; 26.92; 27.67; 19.46; 16.11 | — |
| SECONDARY General and Diabetes-specific Technology Use |
21; 19.71; 21.59; 21; 21.19; 20 | — |
| SECONDARY Center for Epidemiologic Studies Depression Measure |
15.35; 9.57; 13.76; 10.64 | — |
| SECONDARY Child Health Utility 9D |
2; 1; 0; 0; 2; 1 | — |
| SECONDARY Hemoglobin A1c |
10.61; 10.64; 8.17; 7.5 | — |
| SECONDARY C-peptide |
0.66; 0.55; 0.14; 0.15 | — |
Eligibility Criteria
Inclusion Criteria
To be eligible for the study, a child must meet the following criteria:
- Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- Time since diagnosis of no longer than one month
- Age between 2 and 17 years
- Parental consent (and assent from the child where applicable) to participate in the study
- No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
To be eligible for the study, a parent must meet the following criteria:
- Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- Age of 18.0 years or older
- Parent comprehends written English
- Parent understands the study protocol and signs the informed consent document
Exclusion Criteria
The presence of any of the following is an exclusion for the study:
- Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Child is unable to completely avoid acetaminophen for duration of study
Data sourced from ClinicalTrials.gov (NCT02734667). 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.