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

This study has been completed.
Sponsor:
Information provided by:
The Royal Bournemouth Hospital
ClinicalTrials.gov Identifier:
NCT00482443
First received: June 4, 2007
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Other: A software programme in mobile telephone
Other: Standard Education Programme.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Royal Bournemouth Hospital:

Primary Outcome Measures:
  • The difference in HbA1c between the patient in the DID group and in the standard education group. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482443

Locations
United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
Sponsors and Collaborators
The Royal Bournemouth Hospital
Investigators
Principal Investigator: David Kerr, Doctor Royal Bournemouth Hospital
Principal Investigator: Anita Bowes, Dietitian Royal Bournemouth Hospital
  More Information

No publications provided

Responsible Party: Professor David Kerr., Royal Bournemouth Hospital.
ClinicalTrials.gov Identifier: NCT00482443     History of Changes
Other Study ID Numbers: DID
Study First Received: June 4, 2007
Last Updated: July 8, 2008
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014