Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice

Study Overview
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Brief Summary
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The Diabetes Interactive Diary (DID) is both a CHO (carbohydrates )/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional and patient by SMS messages. Aim of the study is to compare an insulin regimen of insulin glargine + prandial insulin glulisine associated with a telemedicine system to teach CHO counting (DID) with the same insulin regimen administered according to usual practice.

Official Title
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An Open Label, Multicentre, Randomized Study of Insulin Glargine + Prandial Insulin Glulisine Associated With a Telemedicine System for Carbohydrates Counting vs. Insulin Glargine + Prandial Insulin Glulisine Associated With Common Practice

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Diabetes Interactive Diary (DID)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with type 1 diabetes as defined by the criteria of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (29) Males and females Age equal or more than 18 years Patients not habitually using CHO (carbohydrates) counting Self monitoring blood glucose (SMBG) at least 3 times a day Four basal-bolus daily injections of short-acting and long-acting insulin analogues HbA1c equal or more than 7.5% Female patients have to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or IUD); A full study-specific informed consent must be obtained in writing for all subjects Exclusion Criteria: Multiple daily injections of NPH insulin or soluble rapid insulin or Continuous Subcutaneous Insulin Infusion (CSII) therapy Mental conditions, depression, or high anxiety rendering the subject unable to understand the nature, scope, and possible consequences of the study Eating disorders Pregnancy / lactation. Any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases or infective diseases making implementation of the protocol or interpretation of the study results difficult Any disease or condition including abuse of illicit drugs, prescription medicines or alcohol that in the opinion of the investigator may interfere with the completion of the study Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin + DID<br>Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections per day of insulin glulisine associated with basal insulin glargine; the DID will be used to estimate the CHO content of the food intended to eat. Insulin doses in this group will be adjusted based on DID calculations and pre-meal BG values. | Device: Diabetes Interactive Diary (DID)<br>* DID is both a CHO/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional (physician or dietitian) and patient by SMS messages.<br>|
| No Intervention: insulin + usual care<br>Three prandial (before or at the end of meal administration, based on doctor counselling and patient decision) injections of insulin glulisine associated with basal insulin glargine. Insulin doses in group B will be adjusted based on SMBG values reviewed during the doctor office visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of glycosylated hemoglobin |  | from baseline every three months until the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose (BG) levels | Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG) | from baseline every three months until the end of the study | 
| Glucose variability | Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG) | from baseline every three months until the end of the study | 
| Change in body weight and BMI |  | from baseline every three months until the end of the study | 
| Total daily insulin dose, total basal insulin dose, total prandial insulin dose |  | from baseline every three months until the end of the study | 
| Quality of life | the quality of life will be measured by Diabetes Specific Quality of Life Scale (DSQOLS) and Diabetes Treatment Satisfaction Questionnaire (DTSQ) | at baseline and at the end of the study | 
| Frequency of patients with hypoglycemic episodes and frequency of hypoglycemic episodes overall |  | every three months until the end of the study | 
| Frequency of patients with severe and/or symptomatic hypoglycemia and frequency of severe and/or symptomatic hypoglycemic episodes overall |  | every three months until the end of the study | 
| Frequency and times of hypoglycemic events with regard to occurrence during the day (24 hours) and total treatment duration (24 weeks) |  | every three months until the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, telemedicine, self monitoring blood glucose