None listed
Conditions
Brief summary
Phase 2 of the study will assess glucose sensing accuracy of the investigational Pacific Diabetes Technology (PDT) combined continuous glucose monitor (CGM) and insulin delivery device, and compare post meal glycaemia with the EOPatch pump automated insulin delivery (AID) system with a commercially available closed loop system (Tandem Control-IQ system). We hypothesize that the PDT sensor is able to measure interstitial glucose accurately without being affected by the preservatives in insulin. We hypothesize that the EOPatch pump is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes compared with a commercially available closed loop system (Tandem Control-IQ system).
Interventions
Participants in Phase 1 of the study (ACTRN12621000912886) will be offered the option of participating in Phase 2 of the study.
Phase 2: Insulin in Tandem pump and Saline in EOPatch pump
- the EOPatch pump and Tandem pump (delivering via the PDT device) will be used during two in-clinic visits (up to 9 hours each including insertion of devices, baseline measurements and meal challenge) for meal challenges (80g high carbohydrate meal) conducted by a doctor and nurse experienced in managing hypo
Participants in Phase 1 of the study (ACTRN12621000912886) will be offered the option of participating in Phase 2 of the study. Phase 2: Insulin in Tandem pump and Saline in EOPatch pump - the EOPatch pump and Tandem pump (delivering via the PDT device) will be used during two in-clinic visits (up to 9 hours each including insertion of devices, baseline measurements and meal challenge) for meal challenges (80g high carbohydrate meal) conducted by a doctor and nurse experienced in managing hypo/hyperglycaemia during daylight hours in a major university hospital with a full resuscitation team available if necessary - the Tandem pump will be inserted at the start of the study (Day 0) and paired with a Dexcom G6 continuous glucose monitor (CGM) in open loop. The participant's own insulin pump will be disconnected. The Tandem pump will remain in situ until the end of the study. Education for the use of the Tandem pump, Dexcom G6 CGM and Contour Next One meter will also be delivered during this session. - the PDT device is inserted by study staff at the start of the in-clinic visit for the first meal challenge (Day 14) and the Tandem pump will be connected to it - the EOPatch pump will be inserted by study staff at the start of the in-clinic visit for the meal challenge (Day 14 and 18) and removed at the end of each meal challenge - the order of the meal challenges, in which participants receive closed loop insulin delivery from either EOPatch pump or Tandem Control-IQ system (delivering via PDT device) and saline through the other device, will be randomized, and participants will have monitoring of glycaemia over 6 hours after the carbohydrate load - a 100% insulin bolus based on the participant's insulin to carbohydrate ratio (ICR) will be delivered through one pump and replication of the same volume of saline will be delivered through the other pump - the EOPatch pump will be removed after the meal challenge and all participants will go home with the Tandem Control-IQ system (delivering insulin via PDT device) in open loop until their next in-clinic visit for the second meal challenge (4 days later) - the 2 meal tests will be 4 days apart
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Type 1 diabetes, of at least 6 months duration. - Age 21-75 Years - Insulin pump usage at the time of screening and for at least 3 months prior to screening. - HbA1c between 5.8% and 9.0% - Willingness and ability to follow all study procedures and to attend all clinic visits. - Living with a person knowledgeable regarding the management of hypoglycaemia. - No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months
Exclusion criteria
- Chronic kidney disease as defined by estimated-GFR < 45 ml/min - Inability to read pump or CGM display due to reduced visual acuity - Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months. - Cognitive limitations precluding the participant’s ability to operate the insulin pump. - Any major active medical condition which in the investigator’s opinion precludes involvement in the study. Known active infection such as HIV or hepatitis - Schizophrenia or other untreated mental illness - Chronic substance abuse - Major surgical procedure within 30 days prior to screening - Bleeding disorder, or treatment with anticoagulants - Allergy to Lispro insulin - Allergy to acrylate-based skin adhesives - Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. - Diabetic ketoacidosis or major hypoglycemia within the last 6 months - Insulin resistance as defined by insulin requirement of more than 200 units per day - Use of glucose-lowering medications other than insulin - Need for uninterrupted treatment with acetaminophen
Outcome results
None listed