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Completed

NCT Number: NCT00482443

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A software programme in mobile telephone

Other

Use of Mobile phone technology in maintaining Diabetes Interactive Diary.

Standard Education Programme.

Other

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

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

The Royal Bournemouth Hospital

Other

Registry information

Official study 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

Acronym: DID

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2007
Registry last updated
Jul 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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