Day and Night Closed-loop in Young People With Type 1 Diabetes (DAN05)
Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Eating disorder such as anorexia or bulimia
- Employed by Medtronic Diabetes or with immediate family members employed by Medtronic Diabetes
Sites / Locations
- Stanford University
- University of Colorado Denver School of Medicine Barbara Davis Center
- Yale University
- Nemours Children's Health System
- Indiana University
- University of Cambridge
- Nottingham Children's Hospital
- Southampton Children's Hospital
- The Leeds Teaching Hospitals NHS Trust
- Alder Hey Children's NHS Foundation Trust
- Oxford Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
24/7 closed loop insulin delivery
Insulin pump therapy
The study system includes (1) a CGM that measures glucose levels, (2) a computer program on a smartphone that determines how much insulin is needed, and (3) an insulin pump that delivers the insulin. The name of this closed-loop system used in the US is FlorenceM (Medtronic 640G pump and Guardian3 sensor). The name of this closed-loop system in the UK is FlorenceX (DANA pump and Dexcom sensor). Half of the individuals taking part in the study will use the closed-loop study system for 6 months.
Half of the Subjects will continue using their own insulin pump for 6 months.