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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Other: A software programme in mobile telephone
* Other: Standard Education Programme.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>To assess the efficacy of a Diabetes Interactive Diary in Diabetes Management. | Other: A software programme in mobile telephone<br>* Use of Mobile phone technology in maintaining Diabetes Interactive Diary.<br>|
| Active Comparator: 2<br>Control Arm. Patients will receive standard education programme. | Other: Standard Education Programme.<br>* Control Arm patients will receive a standard education programme designed to help the Type 1 Diabetic manage their condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in HbA1c between the patient in the DID group and in the standard education group. |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |