Type 1 Diabetes
Conditions
Keywords
diabetes, telemedicine, self monitoring blood glucose
Brief summary
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.
Interventions
DEVICEDiabetes Interactive Diary (DID)
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.
Sponsors
Sanofi
LifeScan
Consorzio Mario Negri Sud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of glycosylated hemoglobin | from baseline every three months until the end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability | from baseline every three months until the end of the study | Glucose variability (MAGE, coefficient of variation of mean fasting BG and post-prandial BG) |
| 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 | — |
| blood glucose (BG) levels | from baseline every three months until the end of the study | Changes in BG levels from baseline to end of study (fasting BG, pre-/post-prandial BG, nocturnal BG, mean daily BG) |
| 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 | — |
| Quality of life | at baseline and at the end of the study | the quality of life will be measured by Diabetes Specific Quality of Life Scale (DSQOLS) and Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
Countries
Italy
Contacts
Primary ContactAntonio Nicolucci, MD
Backup ContactMaria C Rossi
Outcome results
None listed