Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03303196|
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperinsulinism Diabetes Pancreatic Diseases Pancreatectomy; Hyperglycemia||Device: Bihormonal Bionic Pancreas||Not Applicable|
The management of diabetes following pancreatectomy for hyperinsulinism (HI) generally consists of the same approaches that are used for individuals with type 1 diabetes (T1D). However, there are significant differences in individuals with HI and post-pancreatectomy diabetes that increases the risk of hypoglycemia in these individuals and prevent achieving tight glycemic control. Individuals with HI have glucagon deficiency and unlike T1D, those with HI and post-pancreatectomy diabetes have residual dysregulated insulin secretion that results in marked hypo- and hyper-glycemia. Furthermore, pancreatic insufficiency can result in disturbances in nutrient absorption and fluctuations in glucose concentrations.
Current treatment approaches with intermittent subcutaneous insulin administration or insulin pump therapy offer inadequate glycemic control in these individuals. We propose a novel approach to the management of these individuals with the bihormonal bionic pancreas to replace both hormones, insulin and glucagon, through an automated glycemic management system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||This will be an open-label, pilot clinical trial to assess efficacy and safety of the bihormonal bionic pancreas in children and young adults with HI who have developed post-pancreatectomy diabetes. Subjects will be studied during two research inpatient admissions at the CHOP HI Center. The order of the interventions will be randomized.|
|Masking:||None (Open Label)|
|Official Title:||Bihormonal Bionic Pancreas for the Treatment of Diabetes Post-Pancreatectomy in Children With Congenital Hyperinsulinism - A Pilot Study|
|Actual Study Start Date :||April 9, 2018|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||September 30, 2019|
Experimental: Bihormonal Bionic Pancreas Admission
Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
Device: Bihormonal Bionic Pancreas
A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
No Intervention: Standard Care Admission
Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
- Mean plasma glucose level. [ Time Frame: Days 2-3 of each admission ]Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 3 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
- Mean proportion of hypoglycemia. [ Time Frame: Days 2-3 of each admission ]Mean proportion of time that the CGMS-measured plasma glucose concentration was less than 60 mg/dL during Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
- Mean CGMS-defined plasma glucose level. [ Time Frame: Days 2-3 of each admission ]Average plasma glucose level as measured by the CGMS during Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
- Time spent in pre-defined glucose ranges. [ Time Frame: Days 2-3 of each admission ]
Fraction of time spent within each of the following glucose ranges:
- < 50 mg/dL
- < 60 mg/dL
- < 70 mg/dL
- 70-120 mg/dL
- 70-180 mg/dL
- >180 mg/dL and
- >250 mg/dL.
- Percentage of non-hyperglycemic subjects. [ Time Frame: Days 2-3 of each admission ]Percentage of subjects with mean CGMS < 154 mg/dL (estimated average glucose corresponding to an A1c of 7%).
- Percentage of hypoglycemic episodes among subjects. [ Time Frame: Days 2-3 of each admission ]Percentage of schedule fingerstick checks < 70 mg/dL, < 60 mg/dL, <50 mg/dL.
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): NCT03303196
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Diva D De Leon, MD, MSCE||Children's Hospital of Philadelphia|
|Principal Investigator:||Arpana Rayannavar, MD||Children's Hospital of Philadelphia|