Type 1 Diabetes | Outpatient Reduction of Nocturnal Hypoglycemia by Using Predictive Algorithms and Pump Suspension in Children
Type 1 Diabetes research study
What is the primary objective of this study?
The purpose of this study is to see whether low blood sugar at night can be reduced by using a system that turns off the insulin pump automatically. The study system includes a continuous glucose monitor (CGM) and an insulin pump. The CGM and pump work with a regular laptop computer. A The system works by (1) measuring the glucose levels under the skin with the CGM, (2) using a computer program on the laptop to predict whether a low blood sugar is likely to occur, and (3) turning off the insulin pump when the computer program predicts that a low blood sugar will occur. We have tested the system in the home environment in individuals with type 1 diabetes age 15 years and older. We have found an indication that the system can decrease the frequency of hypoglycemia. We have not had any serious cases of high blood sugars or other problems. We are now ready to further test the system in the home environment in a younger age group to learn more about its ability to reduce overnight low blood sugar risk. This study has several phases and will take about 3 months for a patient to complete. - First, the patient will use the CGM and pump at home for up to 15 days with the help of a parent/guardian. This is done to determine if the patient meets our study criteria to proceed with the next phase of the study. - If the patient is eligible to continue in the study, the patient will need to use the full study system for at least 5 nights at home with the help of a parent/guardian. This is done to make sure the patient and parent/guardian are able to use the system correctly. The patient may participate in starting and stopping the system at home, but the parent/guardian is responsible for making sure it is used as instructed. - After that, the patient will be asked to use the study system each night for an additional 6 to 8 weeks. The parent/guardian will remain responsible for making sure the system is used as instructed. The study will include about 90 individuals with type 1 diabetes at 3 clinical centers in the United States and Canada. First a study of children 8 to less than 15 years old will be done. Then, a study of children 3 to less than 8 years old will be conducted.
Who is eligible to participate?
Inclusion Criteria: - Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months - Age 3 to <15 years - HbA1c <=8.5% - Availability of internet access for periodic upload of study data Exclusion Criteria: - Diabetic ketoacidosis in the past 3 months - Hypoglycemic seizure or loss of consciousness in past 6 months - History of seizure disorder (except for hypoglycemic seizures) - Cystic fibrosis - Current use of oral/inhaled glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study - History of ongoing renal disease (other than microalbuminuria), or liver disease (Creatinine is > 1.5 mg/dL (132 µmol/L)) - Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as: - Inpatient psychiatric treatment in the past 6 months - Uncontrolled adrenal disorder - Abuse of alcohol - Pregnancy - Liver disease as defined by an Alanine Aminotransferase Test (ALT) greater than 3 times the upper limit of normal
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 1 Diabetes
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Pump suspension algorithmThe study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Pump suspension algorithmThe pump suspension algorithm will be running actively on the study laptop during the night and suspend the pump if the algorithm predicts hypoglycemia.
Standard of CareThe control algorithm will run passively and not suspend the patient's pump.
Start Date: May 2013
Completed Date: September 2014
Phase: Phase 2
Primary Outcome: Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.
Secondary Outcome: Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)
Study sponsors, principal investigator, and references
Principal Investigator: Roy W Beck, MD, PhD
Lead Sponsor: Jaeb Center for Health Research
Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Buckingham BA, Raghinaru D, Cameron F, Bequette BW, Chase HP, Maahs DM, Slover R, Wadwa RP, Wilson DM, Ly T, Aye T, Hramiak I, Clarson C, Stein R, Gallego PH, Lum J, Sibayan J, Kollman C, Beck RW; In Home Closed Loop Study Group. Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis. Diabetes Care. 2015 Jul;38(7):1197-204. doi: 10.2337/dc14-3053. Epub 2015 Jun 6. Erratum in: Diabetes Care. 2015 Sep;38(9):1813.