Glucose control through a bihormonal artificial pancreas in patients after total pancreatectomy for cancer (PANORAMA): multicenter randomized controlled cross-over trial - Dutch Pancreatic Cancer Group (DPCG)

Phase 3

Completed

Conditions: diabetes
10018424

Registration Number: NL-OMON53782

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Patients who underwent total pancreatectomy
Age >= 18 years

Exclusion Criteria

Impaired awareness of hypogycemia;
Total pancreatectomy performed within less than 3 months before start of trial;
BMI >35kg/m2;
HbA1c > 97 mmol/mol;
Presence of a medical or psychiatric condition, longstanding serious adherence
problems, anticipated problems in handling over diabetes control to a device or
use of a medication that could comprise the results of the study or the safety
of the participant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the percentage of time spent in the normal glucose<br /><br>range, defined as sensor glucose values within 70 to 180 mg/dl (3.9 to 10<br /><br>mmol/l).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Mean sensor glucose concentrations;<br /><br>- Glycemic variability; coefficient of variation and standard deviation<br /><br>- Day and night time spent in hypo-, hyper- and euglycemia;<br /><br>- Day and night median glucose concentration;<br /><br>- Daily insulin and glucagon use;<br /><br>- Mean HbA1c and percentage of patients achieving HbA1c <= 53 mmol/mol at<br /><br>baseline and after each treatment period;<br /><br>- Quality of life / patient reported outcomes</p><br>