Clinical trial NCT01474525: Managing Diabetes During Pregnancy in the Wireless Age
Official title: Managing Diabetes During Pregnancy in the Wireless Age: a RCT of Glucose Telemonitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes Mellitus
Type 2 Diabetes Mellitus
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2011-11-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Randomized Controlled Trial (RCT) will test the efficacy of a home blood glucose telemonitoring system against usual care in women with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (T2DM) during pregnancy. We hypothesize that the system can improve glycemic control in patients, assessed using the mean blood glucose during gestation as the primary outcome measure.

Detailed description: Establishing good glycemic control is crucial for the treatment of patients with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (DM2). High levels of blood glucose in pregnancy may lead to complications during delivery and pose threat to the fetus. The self-monitoring of blood glucose (SMBG) by patients at home is used to provide clinicians with information to make adjustments to treatment plans. Patients record the values and present them at their next meeting with the physician. As such, SMBG by the patients is an important part of disease management and a method for clinicians to follow a patient's day-to-day response to a treatment regime.

The system is designed to send the blood glucose values from the patients' glucometers wirelessly to the server where they can be viewed by the patients' health care providers. The system generates automated adherence reminders to patients and alert messages to both patients and their care providers. The system will provide clinicians with better access to the patient data, so that they may better manage their case loads, make timely clinical decisions, and ultimately provide better patient care.

Eligibility criteria: Inclusion Criteria:

* patients must be pregnant
* diagnosed with gestational diabetes or Type 2 diabetes
* must be comfortable with instructions in English and be able to express themselves using simple phrases in English.

Exclusion Criteria:

* unable to complete self monitoring of blood glucose (SMBG) for any reason
* uncomfortable with the use of the telemonitoring equipment
* develop an acute illness requiring hospitalization, where they may deviate from the normal delivery of care
* refusal to sign consent form or to carry out the demands made by the study

Primary outcomes:
measure: Mean blood glucose, based on the highest post-prandial blood glucose reading for each day, by trimester
timeFrame: from the baseline to the delivery date
Secondary outcomes:
measure: Mean fasting and post-prandial blood glucose by trimester
timeFrame: from the baseline to the delivery date
measure: Percentage of values within recommended guidelines
timeFrame: from the baseline to the delivery date
measure: Adherence: Percentage of values recorded over expected number of values
timeFrame: from the baseline to the delivery date
measure: Adherence: Average number of values per day
timeFrame: from the baseline to the delivery date
measure: Onset of labour and mode of delivery
timeFrame: at exit (delivery)
measure: Fetal outcomes: gestational age at delivery, birth weight (by gender), percentage of macrosomia, large for gestational age (LGA) and small for gestational age (SGA), APGAR at 1 and 5 minutes
timeFrame: at exit (delivery)
measure: Perinatal complications (i.e. premature, NICU admission, jaundice, shoulder dystocia, hypoglycemia)
timeFrame: at exit (delivery)
measure: Provider usage: number of logins onto the system, average amount of time spent on the system per week
timeFrame: for the duration of the study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Leadership Sinai Centre for Diabetes
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Alexander G Logan, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
citation: Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
citation: Feig DS, Palda VA. Type 2 diabetes in pregnancy: a growing concern. Lancet. 2002 May 11;359(9318):1690-2. doi: 10.1016/S0140-6736(02)08599-9. No abstract available.
citation: Langer O. Type 2 diabetes in pregnancy: exposing deceptive appearances. J Matern Fetal Neonatal Med. 2008 Mar;21(3):181-9. doi: 10.1080/14767050801929497.
citation: Kinsley B. Achieving better outcomes in pregnancies complicated by type 1 and type 2 diabetes mellitus. Clin Ther. 2007;29 Suppl D:S153-60. doi: 10.1016/j.clinthera.2007.12.015.
citation: Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.