Phase 2 Completed N=20 Randomized Prevention

An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

Type 1 Diabetes

Source: ClinicalTrials.gov NCT01736930 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Mean Morning Blood Glucose (mg/dL)- Algorithm 1 — 158; 125 mg/dl

Summary

The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off. This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include 2 clinical centers in the United States.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Morning Blood Glucose (mg/dL)- Algorithm 1	158; 125	—
PRIMARY Mean Morning Blood Glucose (mg/dL)- Algorithm 2	151; 138	—
PRIMARY Mean Morning Blood Glucose (mg/dL)- Algorithm 3	144; 133	—
PRIMARY Percent Morning Blood Glucose >250 mg/dL - Algorithm 1	3; 3	—
PRIMARY Percent Morning Blood Glucose >250 mg/dL - Algorithm 2	6; 8	—
PRIMARY Percent Morning Blood Glucose >250 mg/dL - Algorithm 3	1; 3	—
PRIMARY Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1	0; 0	—
PRIMARY Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2	3; 1	—
PRIMARY Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3	1; 0	—
PRIMARY Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1	0; 1	—
PRIMARY Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2	7; 0	—
PRIMARY Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3	0; 0	—
SECONDARY Mean Sensor Glucose Overnight - Algorithm 1	158; 145	—
SECONDARY Mean Sensor Glucose Overnight - Algorithm 2	137; 123	—
SECONDARY Mean Sensor Glucose Overnight - Algorithm 3	148; 133	—
SECONDARY Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1	71; 76	—
SECONDARY Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2	90; 91	—
SECONDARY Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3	89; 94	—

Eligibility Criteria

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 >=18.0 years
HbA1c 10 years duration or is over 50 years of age. If creatinine is > 1.5 mg/dL, the subject is excluded.
History of liver disease
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, and/or abuse of alcohol
Pregnancy: A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

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Data sourced from ClinicalTrials.gov (NCT01736930). 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. Informational only — not medical advice.