Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, adolescents, poor control, CGM
Brief summary
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.
Detailed description
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.
Interventions
DEVICEContinuous Glucose Monitor (CGM)
CGM during 24-hr CRC stay.
Sponsors
Nemours Children's Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 12 to \<18 years old * T1D for at least one year * Treatment with insulin pump therapy * A1c ≥9% * Willingness to comply with study procedures
Exclusion criteria
* Current diabetic ketoacidosis * Hypoglycemia unawareness * Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers) * Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants) * Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months) * Skin rashes or conditions that may affect CGM placement and wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of High Glucose Correction Doses Administered. | 24 hrs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Post-meal (2-3 Hour) Glucose Levels | 24 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Type 1 diabetes, HbA1c ≥9% on insulin pumps
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | CGM Use in Adolescents With Poorly Controlled T1D |
|---|---|
| Age, Categorical <=18 years | 10 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 16.3 years |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 24 hrs
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +1 unit | 3 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = 0 units | 7 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -2 units | 0 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -1 unit | 5 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +2 units | 0 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = 0 units | 1 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -2 units | 2 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -1 unit | 5 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +1 unit | 0 sensor/plasma glucose-based insulin dose |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +2 units | 0 sensor/plasma glucose-based insulin dose |
| All Correction Doses Administered | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +2 units | 0 sensor/plasma glucose-based insulin dose |
| All Correction Doses Administered | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = +1 unit | 3 sensor/plasma glucose-based insulin dose |
| All Correction Doses Administered | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -2 units | 2 sensor/plasma glucose-based insulin dose |
| All Correction Doses Administered | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = 0 units | 8 sensor/plasma glucose-based insulin dose |
| All Correction Doses Administered | Number of High Glucose Correction Doses Administered. | Difference between SG and YSI dose calculated (SG-YSI dose) = -1 unit | 10 sensor/plasma glucose-based insulin dose |
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.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Pre- and Post-meal (2-3 Hour) Glucose Levels | Pre-meal glucose, mean (SD) | 157 mg/dL | Standard Deviation 9 |
| Insulin Correction Doses Determined Using Sensor Glucose Readings | Pre- and Post-meal (2-3 Hour) Glucose Levels | Post-meal glucose, mean (SD) | 174 mg/dL | Standard Deviation 10 |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Pre- and Post-meal (2-3 Hour) Glucose Levels | Pre-meal glucose, mean (SD) | 163 mg/dL | Standard Deviation 11 |
| Insulin Correction Doses Determined Using YSI Glucose Readings | Pre- and Post-meal (2-3 Hour) Glucose Levels | Post-meal glucose, mean (SD) | 183 mg/dL | Standard Deviation 12 |