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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?

A randomised trial comparing the outcomes of specialist diabetes nurse advice to patients with insulin-treated diabetes and Diasend, a telehealth system, at home with a matched group of patients receiving advice based on a conventional, clinic-based approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73041596
Enrollment
294
Registered
2012-09-19
Start date
2013-02-01
Completion date
Unknown
Last updated
2016-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

Diasend or the ?usual care? group. The study will involve 294 people of either sex with poorly controlled type 1 or insulin-treated type 2 diabetes. It will use the widely-used and validated Diabetes

Sponsors

South West Yorkshire Partnership NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change in HbA1c between first contact and the end of the study

Secondary

MeasureTime frame
1. Use of resources 2. Patient confidence in self-management

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026