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The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.
Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM in adolescents with poorly-controlled T1D | Experimental | Adolescents with poorly controlled type 1 diabetes on insulin pumps were admitted to the clinical research center (CRC) and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL or specific criteria indicating SG and YSI were very discordant were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor (CGM) | Device | CGM during 24-hr CRC stay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of High Glucose Correction Doses Administered. | Principal study outcome was comparing insulin doses using pre- and post-meal sensor versus plasma glucose values. All insulin dose calculations over a 24-hour period were made using sensor glucose concentrations; these doses were compared to the those calculated as if plasma glucose were to be used instead for dose calculations. | 24 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-meal (2-3 Hour) Glucose Levels | Mean sensor and plasma pre- and post-meal glucose concentrations for all dinner (n=8), bedtime snack (n=8), and breakfast (n=10) during the study period. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry A Fox, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27435145 | Result | Fox LA, Balkman E, Englert K, Hossain J, Mauras N. Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly controlled type 1 diabetes mellitus: a pilot study. Pediatr Diabetes. 2017 Jun;18(4):271-276. doi: 10.1111/pedi.12404. Epub 2016 Jul 20. |
| Label | URL |
|---|---|
| Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly-controlled type 1 diabetes mellitus: a pilot study | View source |
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Type 1 diabetes, HbA1c ≥9% on insulin pumps
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM in Adolescents With Poorly Controlled T1D | Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL or specific criteria indicating SG and YSI were very discordant were met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Adolescents with poorly controlled type 1 diabetes were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Use in Adolescents With Poorly Controlled T1D | Adolescents with poorly controlled T1D were admitted to CRC and CGM was placed. The safety of using real-time sensor glucose (SG) data for treatment decisions in adolescents with poorly controlled type 1 diabetes was assessed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of High Glucose Correction Doses Administered. | Principal study outcome was comparing insulin doses using pre- and post-meal sensor versus plasma glucose values. All insulin dose calculations over a 24-hour period were made using sensor glucose concentrations; these doses were compared to the those calculated as if plasma glucose were to be used instead for dose calculations. | Ten adolescents with poorly controlled type 1 diabetes on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Insulin dose calculations based on sensor glucose were compared to calculations made as if based on plasma glucose. 23 paired sensor/plasma glucose values for corrections were analyzed. | Posted | Count of Units | sensor/plasma glucose-based insulin dose | 24 hrs | sensor/plasma glucose-based insulin dose | sensor/plasma glucose-based insulin dose |
|
AEs were collected for each participant's admission to the CRC over 24 hrs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Group | Adolescents using CGM during the CRC admission | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild hypoglycemia | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry A Fox, MD | Nemours Children's Health | 9046973600 | larry.fox@nemours.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
The insulin doses in this arm were based on calculations using the sensor glucose value. |
| OG001 | Insulin Correction Doses Determined Using YSI Glucose Readings | The insulin doses in this arm were based on calculations using the YSI glucose value. |
| OG002 | All Correction Doses Administered | Insulin correction doses determined using either the sensor or plasma glucose readings |
|
|
| Secondary | Pre- and Post-meal (2-3 Hour) Glucose Levels | Mean sensor and plasma pre- and post-meal glucose concentrations for all dinner (n=8), bedtime snack (n=8), and breakfast (n=10) during the study period. | Posted | Mean | Standard Deviation | mg/dL | 24 hours | sensor/plasma glucose levels | sensor/plasma glucose levels |
|
|
|
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |