Continuous Correction

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Procedure: Continuous Correction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous correction<br>The insulin pump is set to automatically deliver the patient's usual insulin basal rate. The insulin pump bolus calculator is run every 10 minutes by the attending physician. Bolus calculations are based on glucose sensor values. | Procedure: Continuous Correction<br> <br> |
| No Intervention: Control<br>Regular sensor-augmented pump therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. | 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. | Every 5 min for 9 hours on each study day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 
| CGM standard deviation. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 diabetes, Continuous Glucose Monitoring, Insulin pump, Sensor-augmented pump, Continuous correction of high blood glucose