In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000666527
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: John Hunter Children's Hospital
• Public title: In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?
• Scientific title: In people with type 1 diabetes, can an artificial pancreas algorithm improve postprandial glycaemic control following an unannounced meal compared with traditional carbohydrate counting?
• Date of first enrolment: 29/06/2015
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000666527.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Bruce King

• Name: A/Prof Bruce King

Key inclusion & exclusion criteria

Inclusion criteria: 1. Type 1 diabetes mellitus for over 1 year
2. HbA1c less than or equal to 69 mmol/mol (8.5%)
3. Age 12y to 45yo
4. Body mass index less than or equal to 97th percentile
5. No other medical conditions
6. No diabetes complications

Exclusion criteria: 1. Unwilling/unable to comply with study protocol
2. HbA1c > 69 mmol/mol (> 8.5%)
3. Any medical condition other than type 1 diabetes
4. Diabetes complications including gastroparesis
5. Medications that would alter glycaemic response

Age minimum: 12 Years
Age maximum: 45 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Metabolic and Endocrine - Diabetes

Type 1 diabetes;
Type 1 diabetes

Intervention(s)

The Hunter New England Diabetes Research Network (HNEHRN) has developed a novel artificial pancreas algorithm with multiple future food and exercise scenarios called scenario based moving horizon stochastic dynamic programming (SCENIC). SCENIC will allow the integration of multiple inputs, learnt responses and patterning data so the system can cope with events such as food and exercise without hypoglycaemia. This study will determine if SCENIC is capable of maintaining glycaemic control during a meal.
Participants will attend the Hunter Medical Research Institute for 5 consecutive evenings at 4pm, having fasted and not adjusted their insulin since 1pm. Participants will have their blood glucose levels monitored using capillary blood sampling and a glucometer at 15 min intervals from 4-5pm. At 5pm, participants will be given the standardised test meal and their blood glucose levels will continue to be monitored at 15 min intervals until 9pm.
On the first night, no mealtime insulin dose will be administered. On the second night, the usual mealtime insulin bolus will be administered according the the participant's usual clinical care. On nights 3-5, the insulin dose will be determined using SCENIC.
In the event of hypoglycaemia prior to the session, the session will be rescheduled. In the event of hypoglycaemia during a session, the session will be terminated and the participant treated according to their routine clinical care.

Primary Outcome(s)

Mean blood glucose level[30 minute intervals for 4 hours commencing at the time of the meal]

Secondary Outcome(s)

Incidence of hypoglycaemia (<4 mmol/L) measured through capillary blood sampling and a glucometer. [30 minutes intervals for 4 hours commencing at the time of the meal]

Time to peak blood glucose level[30 minute intervals over 4 hours commencing at the time of the meal]

Peak blood glucose level[30 minute intervals over 4 hours commencing at the time of the meal]

Incremental area under the curve below the target blood glucose level (4 mmol/L)[30 minute intervals over 4 hours commencing at the time of the meal]

Blood glucose level at conclusion of trial[4 hours postprandially (i.e. 9pm)]

Incremental area under the curve above the target blood glucose level (10 mmol/L)[30 minute intervals over 4 hours commencing at the time of the meal]

Secondary ID(s)

Nil

Source(s) of Monetary Support

John Hunter Charitable Trust

Ethics review

Status: Approved
Approval date:
Contact:

Hunter New England Human Research Ethics Committee