Assessing the Effectiveness of Diabetes Interactive Diary (DID) in Diabetes Management

Type 1 Diabetes Mellitus Clinical Trial

— DID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482443
• Other study ID #: DID
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: July 8, 2008
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: July 2008
• Source: The Royal Bournemouth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or over

• 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:

• Mental conditions, depression or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
The Royal Bournemouth Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in HbA1c between the patient in the DID group and in the standard education group.		6 month	No
Secondary	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.		6 month	No