Assessing the Effectiveness of Diabetes Interactive Diary (DID) in Diabetes Management
NCT ID: NCT00482443
Last Updated: 2008-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2007-03-31
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients will be randomized to the standard education programme run for 4 full days over a 4 week period or to the DID programme run as three 2-hour sessions over a two-week period.
The DID is a novel software programme installed on the patient's mobile telephone. It facilitates the communication between the dietitian and the patient by using SMS text messages, so that the dietitian can monitor glycaemic control and suggest adjustments if necessary. It can be described as a little computer, where the patient can record their blood glucose value, the amount of insulin injected and the amount of carbohydrate consumed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
To assess the efficacy of a Diabetes Interactive Diary in Diabetes Management.
A software programme in mobile telephone
Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
2
Control Arm. Patients will receive standard education programme.
Standard Education Programme.
Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A software programme in mobile telephone
Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
Standard Education Programme.
Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not habitually using carbohydrate counting and insulin dose adjustment
* Testing their blood sugar levels at least 3 times a day
* Using multiple daily injections of short-acting and long-acting insulin analogues
* With HbA1c between 7.5% and 10%
* Familiar with the use of mobile phones and possess a personal SIM card.
Exclusion Criteria
* Eating disorders
* Pregnancy
* Any clinically significant major organ system disease or infective diseases
* Any disease or condition or abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study procedures
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Royal Bournemouth Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Royal Bournemouth Hospital.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Kerr, Doctor
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Anita Bowes, Dietitian
Role: PRINCIPAL_INVESTIGATOR
Royal Bournemouth Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DID
Identifier Type: -
Identifier Source: org_study_id