Insulin Administration Plus a Telemedicine System (Diabetes Interactive Diary - DID) vs Insulin Plus Common Practice (DID3)

Consorzio Mario Negri Sud

Status and phase: Unknown; Phase 3

Conditions: Type 1 Diabetes

Treatments: Device: Diabetes Interactive Diary (DID)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01192711

MTD003

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

insulin + DID

Experimental group

Description:

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.

Treatment:

Device: Diabetes Interactive Diary (DID)

insulin + usual care

No Intervention group

Description:

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.