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

NCT ID: NCT02040571

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

At present, decisions regarding insulin dosing are made by the patient with intermittent support from their medical team. Even with glucose sensor augmented insulin pump therapy (SAPT), representing the most advanced technology currently available, there are emotional and intellectual demands placed upon the patient with the most well-educated, intelligent and diligent patients often unable to perfectly match insulin delivery with their varying requirements. SAPT does improve glycaemia in comparison with insulin pump therapy alone though a significant proportion of patients will still not meet target HbA1c (<7.0%). A Closed Loop (CL) system whereby a computerised algorithm reviews continuous glucose information to determine a T1D patient's insulin requirements and controls insulin delivery will potentially have a major impact upon acute and chronic complications of diabetes as well as upon their quality of life. Overnight glycaemic control, without the added challenge of meals, physical activity and stress, is a realistic initial application of CL in clinical practice.

This study aims to evaluate insulin pump therapy with an overnight CL system in comparison with current best available technology represented by SAPT in Type 1 Diabetes (T1D) patients, in both hospital and then at home. Outcomes of interest will include metabolic control and performance of the Medtronic CL overnight system compared with SAPT (OL), in both the Clinical Trials Centre (CTC) and in the home setting; the relationship between night-time and day-time metabolic control with CL and OL and nocturnal clinical, hormonal and inflammatory factors that may influence subsequent daytime metabolic control; anti-insulin antibody titres and dissociation constants (Rd) upon CL algorithm performance; sleep quality, cognition, satisfaction with treatment and psychological parameters.

A two phase randomised crossover study design is to be employed with the first phase conducted for a single night in the clinical trials centre and the second phase over 5 days in an ambulatory setting.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed Loop

Group Type: EXPERIMENTAL

Closed Loop

Intervention Type: 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).

Open Loop

Group Type: ACTIVE_COMPARATOR

Open Loop

Intervention Type: 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.

Interventions

Closed Loop

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).

Intervention Type: DEVICE

Open Loop

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.

Intervention Type: DEVICE

Other Intervention Names

Closed Loop Glucose-Sensing Insulin-Delivery System; Sensor Augmented Pump Therapy (SAPT)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

St Vincent's Hospital Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Amin Sharifi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Norman O'neal

Role: PRINCIPAL_INVESTIGATOR

St Vincent's Hospital Melbourne

Locations

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Countries

Australia

Other Identifiers

U1111-1151-3297

Identifier Type: -

Identifier Source: org_study_id