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

NCT00482443 | Completed

• 1 other identifier: DID
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The difference in HbA1c between the patient in the DID group and in the standard education group.

  6 month

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

To assess the efficacy of a Diabetes Interactive Diary in Diabetes Management.

Other: A software programme in mobile telephone

2

ACTIVE COMPARATOR

Control Arm. Patients will receive standard education programme.

Other: Standard Education Programme.

Interventions

A software programme in mobile telephone OTHER

Use of Mobile phone technology in maintaining Diabetes Interactive Diary.

1

Standard Education Programme. OTHER

Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Bournemouth Hospital: lead

Study Sites (1)

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Kerr, Doctor

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

• Anita Bowes, Dietitian

  Royal Bournemouth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: March 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 10, 2008

Record last verified: 2008-07

Locations

GB (1)