Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482443
Status:
COMPLETED
Last Update Posted:
2008-07-10
First Post:
2007-06-04
Brief Title:
Assessing the Effectiveness of Diabetes Interactive Diary DID in Diabetes Management
Sponsor:
The Royal Bournemouth Hospital
Organization:
The Royal Bournemouth Hospital
Study Overview
Official Title:
A Multinational Randomised Study of the Efficacy of the Diabetes Interactive Diary DID a CarbohydratesInsulin Bolus Calculator and a Telemedicine System Based on the Communication Between Physician or Dietitian and Patient by SMS
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DID
Brief Summary:
For people with Type 1 Diabetes blood glucose control is achieved by matching insulin doses directly to the amount of carbohydrate consumed We are looking at new ways to help our patients with type 1 diabetes manage their diabetes control more effectively We are testing if Diabetes Interactive Diary DID a novel programme designed to be used on a mobile phone can represent an important tool in carbohydrate counting while avoiding the use of complex calculations and in depth knowledge about the carbohydrate content of their food
Detailed Description:
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 75 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None