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

NCT ID: NCT01525784

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-06-30

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.

Conditions

Hypoglycemia; Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rt-CGMS

Using Rt-CGMS, approved by ministry of health as part f clinical care

No interventions assigned to this group

Control

Not approved or suggested for RtCGMS. Other acceptabl means of therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 1-18 years
• Type 1 Diabetes Mellitus

Exclusion Criteria

• Refusal to participate

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: collaborator

Wolfson Medical Center

OTHER_GOV

Sponsor Role: collaborator

The Chaim Sheba Medical Center

OTHER

Sponsor Role: collaborator

Kaplan Medical Center

OTHER

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh MC

Dr. Marianna Rachmiel, Assaf Haroffeh Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianna rachmiel, md

Role: PRINCIPAL_INVESTIGATOR

Assaf Haroffeh Medical Center

Locations

Soroka University Medical Center

Beersheba, , Israel

Wolfson Medical Center

Holon, , Israel

Sheba Medical Center

Tel Aviv, , Israel

Assaf harofeh Medical Center

Ẕerifin, , Israel

Countries

Israel

Central Contacts

Marianna Rachmiel, MD

Role: CONTACT

mariannar@asaf.health.gov.il

972-8-9779133

Facility Contacts

Nta Lebental

Role: primary

Zohar Landau, MD

Role: primary

Orit Hamiel, MD

Role: primary

Marianna Rachmiel, MD

Role: primary

mariannar@asaf.health.gov.il

References

Rachmiel M, Landau Z, Boaz M, Mazor Aronovitch K, Loewenthal N, Ben-Ami M, Levy-Shraga Y, Modan-Moses D, Haim A, Abiri S, Pinhas-Hamiel O. The use of continuous glucose monitoring systems in a pediatric population with type 1 diabetes mellitus in real-life settings: the AWeSoMe Study Group experience. Acta Diabetol. 2015 Apr;52(2):323-9. doi: 10.1007/s00592-014-0643-6. Epub 2014 Sep 16.

Reference Type: DERIVED

PMID: 25223531 (View on PubMed)

Other Identifiers

88\11

Identifier Type: -

Identifier Source: org_study_id