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|ClinicalTrials.gov Identifier: NCT02162004|
Recruitment Status : Terminated (Technical problems)
First Posted : June 12, 2014
Last Update Posted : August 31, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Procedure: Continuous Correction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sensor-Augmented Continuous Correction in Insulin Pump-Treated Type 1 Diabetes|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Continuous correction
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
No Intervention: Control
Regular sensor-augmented pump therapy.
- Percentage of time CGM values are in the target range 3.9-8.0 mmol/l in the time period 8:00-17:00. [ Time Frame: 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.
- Mean CGM glucose value. [ Time Frame: Every 5 min for 9 hours on each study day. ]
- Percentage of time when CGM values are < 3.9 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
- Percentage of time when CGM values are > 8.0 mmol/l. [ Time Frame: Every 5 min for 9 hours on each study day. ]
- CGM standard deviation. [ Time Frame: Every 5 min for 9 hours on each study day. ]
- Number of hypoglycemic episodes. [ Time Frame: Every 5 min for 9 hours on each study day. ]
- Amount of insulin delivered. [ Time Frame: Every 30 min for 9 hours on each study day. ]
- Positive Incremental Area Under the Curve [ Time Frame: Every 5 min for 9 hours on each study day. ]
- Mean absolute relative difference. [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162004
|Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Signe Schmidt, MD, PhD||Hvidovre University Hospital|