Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

University of Minnesota (UMN)

Status: Completed

Conditions: Chronic Pancreatitis; Diabetes Mellitus

Treatments: Device: Closed Loop Insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01945138

CLTPIAT2013

21856 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).

Full description

OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.

Enrollment: 14 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing total pancreatectomy and islet auto-transplantation.
• Patients ages 21 to 64 years old

Exclusion criteria

• Preexisting diabetes
• Use of acetaminophen during study period, which interferes with CGM sensor function
• Any medical condition requiring corticosteroids
• Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
• Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Control

No Intervention group

Description:

Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.

Closed Loop Insulin

Experimental group

Description:

Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.

Treatment:

Device: Closed Loop Insulin