Update on PLGM Trial: Learnings Investigators: B. King, F Cameron, - - PowerPoint PPT Presentation

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Nov 30, 2022 262 likes •466 views

Update on PLGM Trial: Learnings Investigators: B. King, F Cameron, E A Davis, J Fairchild, T W Jones, G Ambler Study Nurses: J Nicholas, S Oates, R Gebert, J Klimek, K Heels, A Crawford Project Manager: C Czank Coordinators and Data

SLIDE 1

Update on PLGM Trial: Learnings

Investigators:

B. King, F Cameron, E A Davis, J Fairchild, T W Jones, G Ambler

Study Nurses: J Nicholas, S Oates, R Gebert, J Klimek, K Heels, A Crawford Project Manager: C Czank Coordinators and Data management: M Abraham,, J Nicholas, H Roby, N Paramalingam, Rachelle Kalic Administration: T Commisso Other Key Personnel: A Brnabic, R Davey (exercise physiologist) Key Support JDRF Staff

SLIDE 2

Pathway to an Artificial Pancreas: Feedback control of insulin delivery

A.Kowalski

SLIDE 3

Low glucose suspend study

50 100 150 200 Sensor Glucose (mg/dL)

Switch

SLIDE 4

CGM Cost-effectiveness Analysis:

Sensor Augmented LGS Pump vs Standard Insulin Pump

SLIDE 5

Can hypoglycaemia be predicted and prevented with sensor-augmented pump therapy and an imbedded algorithm?

Predictive Low Glucose Management (PLGM) System
Suspend before Low
SmartGuardTM

Next Question:

SLIDE 6

Stage 1 : In-Clinic studies Stage 2 : RCT Home studies

Australian Paediatric Diabetes Technology Research Group (JDRF CRN)

SLIDE 7

Predictive Low Glucose Management System Algorithm :

Calculates the rate of decline in sensor glucose. Predictive Horizon of 30 minutes

Modifiable features :

Hypoglycaemic threshold : 3.9mmol/L

Pump resumption:

2 hour fixed suspend or if auto-resumption parameters are met

5.5 30 4.1 5.5 30 3.9

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SC insulin bolus PLGM on PLGM off Exercise PLGM on PLGM on PLGM off PLGM off ↑Basal

In Clinic Studies

Completed 2014

SLIDE 11

Positive Outcomes

Demonstrated the feasibility of performing protocols

in multiple sites

Increased individual capacity of individual sites and of

trial coordination

Enhanced collaboration and track record of such
Junior training in clinical research
Engagement of other investigators and disciplines:

exercise, health economic, psychologist

Interesting results and contributions: presentations and

publications

SLIDE 12

Multisite RCT: in progress

Predictive Insulin Suspend vs Sensor Augmented

Pump Therapy

Primary Outcome: Time spent with Glucose Value

<3.3mmol/l as measured by CGM

Adolescents
Total number = 175 , 6 months

SLIDE 13

Learnings

1. General
2. Specific for technologies

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Learnings: 1 General

1. Time
2. Flexibility
3. Staffing
4. Coordination
5. Ethics and Governance and contracts
6. Communications
7. Trial governance
8. Data-handling
9. Funder support

SLIDE 15

Flexibility

Hypoglycaemia unawareness
Quality of life and compliance information

SLIDE 16

Learnings: 2 Specific for technologies

1. New ground
2. Flexibility
3. Relationship to industry
4. Multifaceted approach and outcomes
5. Very large data sets
6. Clinician as well as patient dependant

SLIDE 17

INDUSTRY FUNDERS PATIENTS

INDEPENDENT CLINICAL RESEARCH TEAMS

SLIDE 18

Outcome Measures for Technologies

Glycaemic

– Aic – Variability – Hypoglycemia

Events
CGM defined
Burden

– Of the use of the technology – Of diabetes, hypoglycaemia fear, quality of life

Economic

– Funders – Patients

SLIDE 19

Improvements

Contract management
Communications and face to face meetings
Data management

SLIDE 20

Reasons for success

Funding for Clinical Research: CRN
Strong collaborative sites and investigators
Strong interest from Type 1 community
International support
Unrestricted support from industry