Diasend study: Does nurse advice using blood glucose data uploaded to the Diasend website improve blood glucose control for insulin-treated diabetes patients, and their well-being, compared with standard care, where blood glucose data are taken from journals or meters?

Not Applicable

Completed

• Conditions: Insulin-dependent diabetes mellitus; Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN73041596
• Lead Sponsor: South West Yorkshire Partnership NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-19
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

1. Type 1 (not receiving insulin via a pump) or insulin-treated type 2 diabetes with an HbA1c (documented within the previous 3 months) of between 7.5% (58 mmol/mol) and 11.0% (97 mmol/mol)
2. Aged 21 years or more
3. Duration of diabetes of at least 2 years
4. BMI <40 kg/m2
5. In patients with insulin-treated type 2 diabetes, oral medication (ie no changes in dosage) must have been stable for at least 6 weeks
6. Able to attend clinic and be available for telephone consultations at the requisite times
7. Able and willing to perform blood glucose monitoring using a blood glucose meter at least twice every other day and, ideally, four times daily
8. Appropriate equipment at home to upload blood glucose levels to the Diasend web-site using the Diasend uploader
9. Willing to monitor and record signs and symptoms of hypoglycaemia

Exclusion Criteria

1. Type 1 diabetes receiving insulin via a pump
2. Treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist
3. Pregnancy
4. Disruption of liver (ALT and/or AST greater than three times the upper limit of normal at screening) or kidney (eGFR less than 50 mls/min/1.72m^2) function that might affect insulin action
5. Clinically relevant cardiovascular, respiratory, hepatic, neurological, endocrine or other major disease making implementation of the protocol or interpretation of the study results difficult
6. Any condition that, in the investigator?s judgement, is likely to cause the patient to be unable to understand the information in the Patient Information Sheet or provide informed consent or to cooperate fully with the protocol
7. History of drug or alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c between first contact and the end of the study

Secondary Outcome Measures

Name	Time	Method
1. Use of resources<br>2. Patient confidence in self-management