Day and Night Closed-loop in Young People With Type 1 Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System Diseases, Autoimmune Diseases

In brief

The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group). It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy. Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).

Key facts

Study ID: NCT02925299
Run by: Jaeb Center for Health Research
People needed: 131
Starts: 2017-05-12
Expected to finish: 2020-08-27
Last updated by the study team: 2021-02-02

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥6 and <19 years
Type 1 diabetes as defined by WHO (51) for at least 1 year [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases with are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).']
Use of an insulin pump for at least 3 months, with good knowledge of insulin self-adjustment by subject or caregiver as judged by the investigator
Using U-100 rapid acting insulin analogues insulin Aspart or Lispro only
Willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements per day day
Screening HbA1c ≥ 7.0% (53 mmol/mol) and ≤10 % (86mmol/mol) based on analysis from local laboratory
Literate in English
Willing to wear glucose sensor
Willing to wear closed-loop system at home
Willing to follow study specific instructions
Willing to upload pump and CGM data at regular intervals
Access to WiFi.
Lives with someone who is trained to administer intramuscular glucagon and is able to seek emergency assistance

You may not qualify if…

Living alone
Current use of any closed-loop system
Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
Untreated coeliac disease, adrenal insufficiency, or untreated thyroid disease
Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc.
Known or suspected allergy to insulin
Clinically significant nephropathy (eGFR < 45ml/min) or on dialysis, neuropathy or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator
Recurrent incidents of severe hypoglycaemia (>1 episode) during the previous 6 months (adolescents: severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital; children: severe hypoglycaemia is defined as an event associated with a seizure or loss of consciousness)
Recurrent incidents of diabetic ketoacidosis (>1 episode) during previous 6 months
Unwilling to avoid regular use of acetaminophen
Lack of reliable telephone facility for contact
Total daily insulin dose ≥ 2 IU/kg/day
Total daily insulin dose < 15 IU/day
Pregnancy, planned pregnancy, or breast feeding
Severe visual impairment
Severe hearing impairment
Seizure disorder
Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor)
Illicit drugs abuse
Subject is currently abusing prescription drugs
Alcohol abuse
Use of pramlintide (Symlin), or other non-insulin glucose lowering agents including sulphonylureas, biguanides, DPP4-Inhibitors, , GLP-1 analogues, SGLT-1/ 2 inhibitors at time of screening
Shift work with working hours between 10pm and 8am
Sickle cell disease, haemoglobinopathy, or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening

Where it is running

Stanford University — Palo Alto, California, United States
University of Colorado Denver School of Medicine Barbara Davis Center — Aurora, Colorado, United States
Yale University — Hartford, Connecticut, United States
Nemours Children's Health System — Jacksonville, Florida, United States
Indiana University — Indianapolis, Indiana, United States
University of Cambridge — Cambridge, Cambridgeshire County, United Kingdom
Nottingham Children's Hospital — Nottingham, England, United Kingdom
Southampton Children's Hospital — Southampton, England, United Kingdom
The Leeds Teaching Hospitals NHS Trust — Leeds, West Yorkshire, United Kingdom
Alder Hey Children's NHS Foundation Trust — Liverpool, United Kingdom
Oxford Children's Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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