N/A
Completed N=25
Four Way Crossover Closed Loop With Exercise Detection
Source: ClinicalTrials.gov NCT02862730 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Percent of Time With Sensed Glucose < 3.9 mmol/L — 1.8; 1.2; 2.7; 3.0 percentage of 84 hours
Summary
Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed 530G with Enlite). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm and sensor augmented pump therapy using the subject's own insulin pump.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Time With Sensed Glucose < 3.9 mmol/L |
6.9; 3.5; 7.5; 4.0 | — |
| PRIMARY Percent of Time With Sensed Glucose Between 3.9-10 mmol/L |
78.0; 84.6; 84.4; 79.4 | — |
| SECONDARY Mean Sensed Glucose |
165.9; 154.1; 146.8; 161.9 | — |
| SECONDARY Number of Carbohydrate Treatments |
1.3; 0.8; 1.6; 1.4 | — |
| SECONDARY Percent of Time With Sensed Glucose < 3.0 mmol/L |
0.2; 0.2; 0.6; 0.3 | — |
| SECONDARY Percent of Time With Sensed Glucose > 10 mmol/L |
35.2; 26.1; 21.7; 33.9 | — |
| SECONDARY Number of Events With Capillary Blood Glucose < 3.9 mmol/L |
0.8; 0.7; 1.1; 0.9 | — |
| SECONDARY Number of Events With Capillary Blood Glucose < 3.0 mmol/L |
0.1; 0.1; 0.2; 0.1 | — |
| SECONDARY Mean Amount of Insulin Delivered |
43.8; 44.2; 42.6; 44.1 | — |
| SECONDARY Mean Amount of Glucagon Delivered |
516.1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system with the subject.
- Lives within 20 miles of OHSU.
- A1C = 160 mmHg or diastolic blood pressure >= 100 mmHg despite treatment or who have treatment-refractory hypertension (e.g. requiring four or more medications).
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Subjects will complete a hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R responses.
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Allergy to aspart insulin.
- Allergy to glucagon.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment of acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- Beta blockers or non-dihydropyridine calcium channel blockers.
- Current use of any medication intended to lower glucose other than insulin (ex. use of liraglutide).
- Diagnosis of pheochromocytoma, insulinoma, or glucagonoma, personal or family history of multiple endocrine neoplasia (MEN) 2A, MEN 2B, neurofibromatosis or von Hippel-Lindau disease.
- History of severe hypersensitivity to milk protein.
- Current use of any medication with strong anticholinergic properties, such as antihistamines, sleep aids, and antidiarrheal medications.
- Current use of indomethacin.
- Conditions that may result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by glucagon such as prolonged fasting, starvation or chronic hypoglycemia as determined by the investigator.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
- Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Data sourced from ClinicalTrials.gov (NCT02862730). 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.