Home Testing of Day and Night Closed Loop With Pump Suspend Feature

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 day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone. This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature (intervention group) or by sensor augmented insulin pump therapy (control group). It is expected that up to 100 subjects, aiming for 84 randomised subjects \[42 youth (6 to 21 years), and 42 adults (22 years and older)\], with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres. Subjects who drop out within the first four weeks of the intervention may be replaced. Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device. Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend 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 the time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on CGM glucose levels during the 12 week free living phase. Secondary outcomes are HbA1 at the end of treatment period, the 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.

Key facts

Study ID

NCT02523131

Run by

University of Cambridge

People needed

84

Starts

2016-05-01

Expected to finish

2018-03-01

Last updated by the study team

2018-03-13

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is at least 6 years or older [with equal proportion of youth (6 to 21 years) and adults (22 years and older)]
• The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
• The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
• The subject is treated with one of the rapid acting insulin analogues (insulin Aspart, Lispro or Glulisine)
• The subject is willing to perform regular capillary blood glucose monitoring, with at least 4 blood glucose measurements taken every day
• Screening HbA1c ≥ 7.5% (58.5mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent [with equal proportion of subjects above and below HbA1c 8.5% (69mmol/mol)]
• The subject is literate in English
• The subject is willing to wear glucose sensor
• The subject is willing to wear closed loop system at home
• The subject is willing to follow study specific instructions
• The subject is willing to upload pump and CGM data at regular intervals
• The subject is willing to restrict alcohol consumption to ≤ 2 units per day throughout the study period
• Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.
• The subject lives with someone who is trained to administer intramuscular glucagon and is able to seek emergency assistance.
• The subject has access to WIFi at home.

You may not qualify if…

• Non-type 1 diabetes mellitus including those secondary to chronic disease
• Subject using real-time CGM on regular basis in preceding 3 months
• 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 or thyroid disease or subject is being treated for hypothyroidism at time of screening
• 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
• Subjects with 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
• Adults: one or more episodes of severe hypoglycaemia as defined by American Diabetes Association (33) in preceding 6 months; Youth: recurrent incidents of severe hypoglycaemia during the previous 6 months (Adults and 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);
• Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mmol/l (72 mg/dl)
• 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
• Significantly reduced hypoglycaemia awareness in subjects 18 year and older (screening Gold score > 4)
• Subjects using implanted internal pace-maker
• Patients with medically documented allergy towards the adhesive (glue) of plasters or Subject is 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)
• Subject is currently abusing illicit drugs
• Subject is currently abusing prescription drugs
• Subject is currently abusing alcohol
• Subject is using pramlintide (Symlin) at time of screening
• Subject has elective surgery planned that requires general anaesthesia during the course of the study

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States
• International Diabetes Center at Park Nicollet — Minneapolis, Minnesota, United States
• International Diabetes Centre at Park Nicollet — Minneapolis, Minnesota, United States
• University of Cambridge — Cambridge, United Kingdom
• Wellcome Trust-MRC Institute of Metabolic Science — Cambridge, United Kingdom
• Royal Hospital for Sick Children — Edinburgh, United Kingdom
• Leeds Teaching Hospitals — Leeds, United Kingdom
• Manchester Diabetes Centre, Manchester Royal Infirmary — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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