Clinical Trial Portfolio

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Clinical Trial Portfolio

• Asthma (O2, Isle of Mann DoH): – Observational study of 100 asthmatics in 9 GP surgeries in Thames Valley, ended Jan 2004– Surgery based trial of t+ asthma in Isle of Man, ending Nov 2005

• Diabetes type 1 (Vodafone): – Full RCT of 93 Type 1 patients in Oxford ended Jan 2005

• Diabetes type 2 (Lloyds pharmacy):– Observational study of type 2 patients in 3 pharmacies in Oxford area. Ending Nov 2005

• Cystic fibrosis (O2):– Observational study of 60 CF patients at Bristol Royal Infirmary ending July 2006

• Oncology trial (Vodafone, Roche and Aventis):– 400-patient multi-centre trial starting Nov 2005 (early detection of high toxicity and/or

infection with new chemotherapy drugs)• COPD (O2):

– Observational study of 40 COPD patients at BRI, start Nov 2005• Diabetes Titration (SFR)

– Observation study of 20 titration patients with AFD in France

A randomized controlled trial of the effect of real-time telemedicine support on glycaemic control in young adults with type 1 diabetes

Diabetes and Vascular Disease Group

Department of Primary Health Care, University of Oxford

Department of Engineering Science University of Oxford

The Oxford Diabetes Type 1 clinical trial

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Changes in HbA1c over 9 months

8.0

8.2

8.4

8.6

8.8

9.0

9.2

9.4

Baseline 4 months 9 months

Control

Intervention

HbA

1c (%

)

0.6%, P=0.0001

0.4%, P=0.04

0.2%, P=0.3

Recorded Improvement in HbA1c = 0.7 % points or 8% in 9 months

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450 % increase in proportion achieving HbA1c ≤ 8%

0

5

10

15

20

25

30

35

40

45

50

Baseline 9 months

Control

Intervention

% H

bA1c

≤ 8

%

Difference in change in proportions - P=0.0002

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Type II Diabetes Study

• Poorly-controlled patients (HbA1c > 8%) are brought under control through using t+ diabetes

• Well-controlled patients (HbA1c < 7.4%) remain well controlled

Entry Exit0

1

2

3

4

5

6

7

8

9

10

11

HbA

1c (

%)

HbA1c at entry and exit

Mean age = 58 years (oldest patient was 81 years old) Mean HbA1c at entry = 7.5%; mean HbA1c at exit = 6.8%

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Asthma Solution• Peak flow data recorded and shared in supervised log• Adverse trends sets of alerts to medical personnel or family.• Additional web based notifications alerts patient to changes in climate etc.

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Clinical Trial Outcomes• Thames Valley Asthma Study 91 Patient 6 month study on impact of t+

system

93% delivered one reading per day 74% indicated that it helped them overcome

symptoms 32% reduction in inhaler use

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• Pilot study in France sponsored by SFR• Clinical partners: AFD (French Diabetic

Association) and Centre Hospitalier de Corbeilles-Essonnes (Dr Charpentier)

• 3-month study with 10 patients to be titrated• N=200 study in design

t+ diabetes for insulin titration

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Patient 1 Titration – all BG data

2 month titration including vacation