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Table 2 Study procedures and data collection

From: Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections

Procedures

Baseline

Follow-up: scheduled 3-monthly clinic visit from time of diagnosis

Diagnosis

Prior to start of treatment

 

T0

T + 3

T + 6

T + 9

T + 12

Assessment of eligibility criteria

X

     

Signed consent form

X

     

Randomisation

X

     

Review of concomitant medications

 

X

X

X

X

X

Review of insulin use (insulin requirements)

      

Patient diaries

  

X

X

X

X

General practitioner prescriptions

  

X

X

X

X

CSII pump download

  

X

X

X

X

Review of medical history

X

  

X

 

X

Blood glucose measurement

Xb

X

X

X

X

X

Blood pH measurement

X

     

Demographics

X

     

Study intervention

 

Xa

    

Physical exam

      

Height

X

 

X

X

X

X

Weight

X

X

X

X

X

X

Injection sites

  

X

X

X

X

Symptom-directed

  

(X)

(X)

(X)

(X)

Assessment of adverse events

  

(X)

(X)

(X)

(X)

Clinical laboratory

      

HbA1 c (local analysis)

 

X

X

X

X

X

HbA1 c (central analysis)

 

X

X

X

X

X

Chemistry

(X)

    

X

Haematology

(X)

    

X

Urinalysis

(X)

 

X

X

X

X

Patient completed measures

      

Patient PedsQL

 

X

 

X

 

X

Parent PedsQL

 

X

 

X

 

X

Health utilities index 2

 

X

X

X

X

X

Resource use: RN completed CRF

 

X

X

X

X

X

  1. (X), as indicated/appropriate.
  2. aRandomised treatment will be commenced within 14 days of diagnosis; bmeasurement of blood glucose will be undertaken in the local hospital laboratory at diagnosis and by glucometer at remaining time points. RN: research nurse, CRF: case report form.