Clinical trial NCT01525784: Affect of RT-CGMS as Part of Clinical Care in Type 1 Diabetes Mellitus Patients
Official title: Prospective Short and Long Term Follow up of Pediatric Diabetes Mellitus Patients Receiving RT-CGMS as Part of National Clinical Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoglycemia
Type 1 Diabetes Mellitus
Keywords: rtCGMS
glycemic control
type 1 diabetes mellitus
youth
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Soroka University Medical Center
name: Wolfson Medical Center
name: The Chaim Sheba Medical Center
name: Kaplan Medical Center
First posted: 2012-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients recieving CGMS for treatment group and those without RTCGMS but all other management, for control group.

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.

Eligibility criteria: Inclusion Criteria:

* Age 1-18 years
* Type 1 Diabetes Mellitus

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: to examine prospectively frequency of hypoglycemia
timeFrame: 3 years
Secondary outcomes:
measure: to assess the effect of rt-cgms on quality of life of children and parents
timeFrame: 3 years
measure: To examine prosectively the effect of rt-cgms on glycemic control
timeFrame: 3 years
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: TEl Aviv
country: Israel
facility: Sheba Medical Center
city: Zerifin
country: Israel
facility: Assaf harofeh Medical Center
Study officials:
affiliation: Assaf Haroffeh Medical Center
name: Marianna rachmiel, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.