Trial Outcomes & Findings for Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes (NCT NCT01586065)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

24 hrs

Results posted on

2023-06-28

Participant Flow

Type 1 diabetes, HbA1c ≥9% on insulin pumps

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGM Use in Adolescents With Poorly Controlled T1D n=10 Participants 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.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.3 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Insulin Correction Doses Determined Using Sensor Glucose Readings n=15 sensor/plasma glucose-based insulin dose The insulin doses in this arm were based on calculations using the sensor glucose value.	Insulin Correction Doses Determined Using YSI Glucose Readings n=8 sensor/plasma glucose-based insulin dose The insulin doses in this arm were based on calculations using the YSI glucose value.	All Correction Doses Administered n=23 sensor/plasma glucose-based insulin dose Insulin correction doses determined using either the sensor or plasma 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	5 sensor/plasma glucose-based insulin dose	10 sensor/plasma glucose-based insulin dose
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	1 sensor/plasma glucose-based insulin dose	8 sensor/plasma glucose-based insulin dose
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	0 sensor/plasma glucose-based insulin dose	3 sensor/plasma glucose-based insulin dose
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	0 sensor/plasma glucose-based insulin dose	0 sensor/plasma glucose-based insulin dose
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	2 sensor/plasma glucose-based insulin dose	2 sensor/plasma glucose-based insulin dose

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Insulin Correction Doses Determined Using Sensor Glucose Readings n=26 sensor/plasma glucose levels The insulin doses in this arm were based on calculations using the sensor glucose value.	Insulin Correction Doses Determined Using YSI Glucose Readings n=26 sensor/plasma glucose levels The insulin doses in this arm were based on calculations using the YSI glucose value.	All Correction Doses Administered Insulin correction doses determined using either the sensor or plasma glucose readings
Pre- and Post-meal (2-3 Hour) Glucose Levels Pre-meal glucose, mean (SD)	157 mg/dL Standard Deviation 9	163 mg/dL Standard Deviation 11	—
Pre- and Post-meal (2-3 Hour) Glucose Levels Post-meal glucose, mean (SD)	174 mg/dL Standard Deviation 10	183 mg/dL Standard Deviation 12	—

Adverse Events

CGM Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CGM Group n=10 participants at risk Adolescents using CGM during the CRC admission
Endocrine disorders Mild hypoglycemia	20.0% 2/10 • Number of events 5 • AEs were collected for each participant's admission to the CRC over 24 hrs.

Additional Information

Larry A Fox, MD

Nemours Children's Health

Phone: 9046973600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place