Assessing the Effectiveness of Diabetes Interactive Diary (DID) in Diabetes Management (DID)
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|ClinicalTrials.gov Identifier: NCT00482443|
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : July 10, 2008
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Other: A software programme in mobile telephone Other: Standard Education Programme.||Not Applicable|
This is randomized control trial aimed to evaluate the effectiveness of a DID compare to the standard education approach in order to help the patients with Type 1 diabetes to estimate the carbohydrate in their food and adjust insulin doses. It involves individuals with Type 1 diabetes who are not habitually using carbohydrate counting. They should be 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% and are familiar with the use of mobile phones and possess a personal SIM card.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multinational, Randomised Study of the Efficacy of the Diabetes Interactive Diary (DID), a Carbohydrates/Insulin Bolus Calculator and a Telemedicine System Based on the Communication Between Physician or Dietitian and Patient by SMS|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
To assess the efficacy of a Diabetes Interactive Diary in Diabetes Management.
Other: A software programme in mobile telephone
Use of Mobile phone technology in maintaining Diabetes Interactive Diary.
Active Comparator: 2
Control Arm. Patients will receive standard education programme.
Other: Standard Education Programme.
Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.
- The difference in HbA1c between the patient in the DID group and in the standard education group. [ Time Frame: 6 month ]
- The differences between the two groups in terms of, lipid profile, blood pressure, the number of hypoglycaemic episodes, daily blood sugar fluctuation, total insulin dose, weight changes and patients' satisfaction with the treatment. [ Time Frame: 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482443
|Royal Bournemouth Hospital|
|Bournemouth, Dorset, United Kingdom, BH7 7DW|
|Principal Investigator:||David Kerr, Doctor||Royal Bournemouth Hospital|
|Principal Investigator:||Anita Bowes, Dietitian||Royal Bournemouth Hospital|