The Performance of an Artificial Pancreas at Home in People With Type 1 Diabetes

NCT02040571 | Completed DMC

• 1 other identifier: U1111-1151-3297
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to evaluate the performance of Artificial Pancreas or Closed Loop Glucose-Sensing Insulin-Delivery system in comparison to current best available technology represented by Sensor Augmented Pump Therapy (SAPT) in patients with Type 1 Diabetes.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Continuous glucose monitoring (CGM) time spent in target glycaemic range (4.0-8.0 mmol/L) overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study.

  Participants will be monitored overnight during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).

• Continuous glucose monitoring (CGM) time spent in target glycaemic range (4.0-8.0 mmol/L) from 2000h-0800h in clinical trial centre (phase 1 of the study).

  Participants will be monitored in clinical trial centre (phase 1 of the study), an expected average of 12 hours.

Secondary Outcomes (40)

• CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).

  Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.

• CGM time and area under the curve (AUC) spent above target range (>8.0 mmol/L).

  Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).

• CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).

  Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.

• CGM time spent in hypoglycaemic range (<4.0 mmol/L and <3.0 mmol/L) and number of episodes of symptomatic hypoglycaemia (indicated by glucose sensor and confirmed by meter glucose).

  Participants will be monitored overnight (0000h - 0800h) during the ambulatory phase (Phase 2) of the study, an expected average of 8 hours each night for 4 nights (Day 1-4 of phase 2).

• CGM measures of glycaemic variability (standard deviation and margin of error).

  Participants will be monitored from 2000h-0800h in phase 1 of the study, an expected average of 12 hours.

Study Arms (2)

Closed Loop

EXPERIMENTAL

Device: Closed Loop

Open Loop

ACTIVE COMPARATOR

Device: Open Loop

Interventions

Closed Loop DEVICE

A total of 24 participants with T1 Diabetes with sensor augmented insulin pump therapy (SAPT) experience will be recruited from four tertiary hospitals and will enter an un-masked randomised-control crossover trial, with a run-in period followed by two phases (in-hospital and at-home) in each of two stages (Closed Loop and Open Loop in random order). Closed Loop will be the intervention for this study, and its performance will be assessed compared to Open Loop (control treatment).

Also known as: Closed Loop Glucose-Sensing Insulin-Delivery System

Closed Loop

Open Loop DEVICE

The performance of closed loop system will be compared to open loop system (Sensor Augmented Pump Therapy). Therefore, the Open Loop system will be the control treatment. In stage 1 of study, participants are randomized to either closed loop (CL) or open loop (OL). In stage 2, all participants will be crossed to the opposite study arm. Throughout the study, those who randomised to OL will receive exactly the same medical attention as the CL participants.

Also known as: Sensor Augmented Pump Therapy (SAPT)

Open Loop

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged greater than 14 years able to provide informed consent.
• T1 Diabetes for a minimum of 6 months (fasting C-peptide levels less than 50 pmol/L).
• HbA1c less than 8.5%.
• Experience with a continuous glucose sensor with established basal insulin infusion patterns, insulin to carbohydrate ratios, regular use of the insulin bolus calculator, can insert/ change sensor by themselves, can recharge transmitter, and has experience in reading real time continuous glucose monitoring (RT-CGM) data.
• Accurate carbohydrate counting.
• Experience in uploading pump information to web.
• Residing in Melbourne or Perth.
• Willing to comply with the study protocol requirements inclusive of those requirements related to participant safety.

You may not qualify if:

• Requiring greater than 150 units of insulin/day.
• Diabetic ketoacidosis (DKA) within the past 4 weeks.
• Hypoglycaemic unawareness (Gold score = 4) while on SAPT
• More than 2 severe hypoglycaemic episodes within the last 12 months
• Pregnant or planning pregnancy within study period.
• Renal impairment (eGFR less than 60ml/min).
• Current or recent (less than 4 weeks) inhaled or oral steroid therapy.
• Dermatological conditions (eg psoriasis) involving the region of glucose sensor/ insulin delivery cannula insertion.
• Subject has physical limitations (eg impaired vision) that would compromise operation of the closed loop system.
• Currently involved in another investigational study.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead
• Juvenile Diabetes Research Foundation: collaborator
• Medtronic: collaborator

Study Sites (1)

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Norman O'neal

  St Vincent's Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

AU (1)