N/A
N=14
Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
Chronic Pancreatitis · Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01945138 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Study Period: Average Serum BG — 130; 111 mg/dL — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Closed Loop Insulin (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Period: Average Serum BG |
130; 111 | 0.003 sig |
| PRIMARY Study Period: Serum BG Standard Deviation |
21.0; 14.1 | 0.115 |
| SECONDARY Study Period: Continuous Glucose Monitor (CGM) BG Average |
125; 114 | 0.193 |
| SECONDARY Study Period: Continuous Glucose Monitor Standard Deviation of BG |
21.0; 20.1 | 0.848 |
| SECONDARY Study Period: Percent Time BG in Range 70-140 mg/dL |
70.6; 89.2 | 0.074 |
| SECONDARY Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL |
1615; 146 | 0.38 |
| SECONDARY Study Period: % of Time CGM BG <70 mg/dL |
4.8; 1.1 | 0.461 |
| SECONDARY Study Period: CGM AUC With Glucose> 140 mg/dL |
7860; 2025 | 0.205 |
| SECONDARY Study Period: % of Time CGM BG > 140 mg/dL |
23.7; 9.7 | 0.157 |
| SECONDARY Study Period: Morning C-peptide |
1.6; 1.3 | 0.443 |
| SECONDARY Study Period: Daily Insulin Needs |
0.56; 0.26 | 0.04 sig |
| SECONDARY Day 14 Follow-Up: Average Serum BG |
135; 106 | 0.401 |
| SECONDARY Day 14 Follow-Up: C-Peptide |
1.0; 1.6 | 0.22 |
| SECONDARY Day 28 Follow-Up: Average Serum BG |
113; 100 | 0.325 |
| SECONDARY Day 28 Follow-Up: C-Peptide |
1.0; 1.7 | 0.311 |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01945138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.