Affect of RT-CGMS as Part of Clinical Care in Type 1 Diabetes Mellitus Patients

• Conditions: Hypoglycemia; Type 1 Diabetes Mellitus

• Registration Number: NCT01525784
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy.Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .

The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years in 2011, indicated for those with recurrent hypoglycemic episodes. So, the aim of the investigators study is to examine prospectively the short and long term effect of the RT-CGMS routine usage, in daily routine life of the diabetic child.

Detailed Description

The incidence of Type 1 Diabetes Mellitus is increasing annually, in all pediatric age groups, especially among infants and toddlers.

However, only 30% of diabetic children manage to achieve and maintain glycated hemoglobin A1c (HbA1c) levels below 8%, although most are treated by intensive insulin therapy by multiple daily injections (MDI) or by subcutaneous continuous insulin infusion (SCII). The presence of high HbA1c levels increase the probability for long term complications of diabetes, as retinopathy, nephropathy and neuropathy.

This failure is attributed to multiple reasons; irregular meals, unpredictable physical activity, behavioral difficulties, refusal to accept the diabetes and maintain the required lifestyle, resistance to insulin, but , most of all fear of hypoglycemia and hypoglycemia unawareness . Further more, recurrent hypoglycemic episodes under the age of 6 years old may cause neurocognitive permanent damage.

Recently, devices for real-time continuous glucose monitoring (RT-CGMS) have been introduced to aid self management of glycemic control. These devices enable the patients to see the interstitial glucose levels continuously, the trends of decrement and increment, and to have alarms prior to a severe hypoglycemic episode .

Only few studies were performed in the pediatric population. One showed a decrement of 0.27% in HbA1c after 1 month and the other a 1 % decrement in 50% of study population after 3 months, but in the adult population. A study performed in the minority group of well controlled diabetic patients (HA1c\<7.5%) demonstrated an increment of 1.56 hours per day of normoglycemia, and less time spent an hypoglycemia among those using RT-CGMS for 26 weeks.

However, those studies were performed in chosen groups and motivated patients, in a state of research with multiple clinic visits and reminders. Those studies do not always reflect the real life benefit of the equipment and its best usage method.

The RT-CGMS was approved in Israel for routine usage in the pediatric population, 0-18 years in 2011, indicated for those with recurrent hypoglycemic episodes.

The aim of our study

* to examine prospectively the short and long term effect of the RT-CGMS routine usage, in daily routine life of the diabetic toddler, child and adolescent on glycemic control, frequency of day time and nocturnal hypoglycemia and quality of life not under a research template.

* to identify the characteristics of those patients who will benefit most of the RT-CGMS routine usage.

* to identify the characteristics of those patients who will not benefit, but will even worsen of the RT-CGMS routine usage

Study design:

This is a prospective multicenter case-control cohort study. We will follow prospectively all patients receiving RT-CGMS as part of their routine management, for a period of 2 years, in five centers of pediatric diabetes care in Israel.

All participants will receive similar guidance and instructions prior to RT-CGMS usage.

All clinic visits, at intervals of 3 months or more will be recorded, including data regarding weight, height, insertion sites, blood glucose average measurements, CGMS measurements and variability, frequency of hypoglycemia, time spent in normoglycemia and HbA1c.

Quality of Life and Anxiety questionnaires will be filled bi-annually.

Study Timeline

• Study First Submitted: 2011-11-03
• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Study First Posted: 2012-02-03
• Last Update Posted: 2012-02-03
• Primary Completion: 2014-01
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age 1-18 years
• Type 1 Diabetes Mellitus

Exclusion Criteria

• Refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to examine prospectively frequency of hypoglycemia	3 years

Secondary Outcome Measures

Name	Time	Method
to assess the effect of rt-cgms on quality of life of children and parents	3 years
To examine prosectively the effect of rt-cgms on glycemic control	3 years	to follow the effect of rt-cgms on hba1c and on bg average and complications

Trial Locations

Locations (4)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel

Wolfson Medical Center; 🇮🇱 Holon, Israel

Assaf harofeh Medical Center; 🇮🇱 Zerifin, Israel

Sheba Medical Center; 🇮🇱 TEl Aviv, Israel