Continuous Correction

Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02162004

Enrollment

Registered

2014-06-12

Start date

2014-06-30

Completion date

2014-12-31

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose

Brief summary

The potential of currently available diabetes technologies could be further exploited. The investigators propose that sensor-augmented insulin pump therapy may be improved by continuous correction, i.e. continuous evaluation of the need for correction boluses. In practice, this is carried out by running the bolus calculator every 10 minutes. The glucose sensor will provide the bolus calculator with glucose input. Many times, the bolus calculator will come to the result that no insulin is needed. However, when the blood glucose is above the pre-set target value and a correction bolus is needed, an appropriate bolus is automatically delivered by the insulin pump. The investigators hypothesize that sensor-augmented continuous correction insulin pump therapy can reduce hyperglycemia without increasing the risk of hypoglycemia in patients with type 1 diabetes.

Interventions

PROCEDUREContinuous Correction

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * T1D ≥ 3 years * CSII ≥ 1 year * HbA1c ≤ 8.0% (64 mmol/mol)

Exclusion criteria

* Pregnancy or nursing * Hypoglycemia unawareness * Gastroparesis * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to the study * Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

Design outcomes

Primary

Measure	Time frame	Description
Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00.	Every 5 min for 9 hours on each study day.	The primary outcome is difference in the percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00 on CC-days and Control-days.

Secondary

Measure	Time frame
Mean CGM glucose value.	Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are < 3.9 mmol/l.	Every 5 min for 9 hours on each study day.
Percentage of time when CGM values are > 8.0 mmol/l.	Every 5 min for 9 hours on each study day.
Number of hypoglycemic episodes.	Every 5 min for 9 hours on each study day.
Amount of insulin delivered.	Every 30 min for 9 hours on each study day.
Positive Incremental Area Under the Curve	Every 5 min for 9 hours on each study day.
CGM standard deviation.	Every 5 min for 9 hours on each study day.

Other

Measure	Time frame	Description
Mean absolute relative difference.	Every 5 min for 9 hours on each study day.	CGM accuracy will be evaluated with Hemocue glucose values as reference (mean absolute relative difference).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026