Retrospective and Prospective Study on Professional Continuous Glucose Monitoring in Insulin-treated Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In people with type 2 diabetes (T2D) without adequate glycemic control for an extended period
      of time, continuous glucose monitoring (CGM) can provide detailed information about daily
      glycemic profile facilitating therapeutic adjustments decision which can contribute to an
      improvement of glycemic control and overall health status.

      The ADJUST study aims to evaluate the impact of CGM systems' use on clinical decision and
      glycemic control of people with badly controlled T2D, already under insulin therapy.
    

Detailed description: 
      Diabetes mellitus (DM) is a growing health problem worldwide. The PrevaDiab study, which
      studied the prevalence of diabetes in Portugal in 2010, estimated a prevalence of 11.7 %,
      representing about 905 000 patients with diabetes. Taking the demographic evolution of the
      Portuguese population, these estimates were updated in 2015, and the global prevalence is
      expected to have risen to 13.3 % of the adult population.

      The International Diabetes Federation (idf) recommends the following glycaemia levels: <100
      mg dL-1 (eq 5.6 mmol L-1) for impaired fasting glucose and <140 mg dL-1 (eq 7.8 mmol L-1) for
      2h glycaemia. Several guidelines recommend frequent glucose measurements as an integral part
      of the patients' education and self-monitoring.

      The percentage of glycated haemoglobin (HbA1c) is used as a long-term glycaemic control
      proxy, as it gives the mean value of the previous 3 months blood glycose concentrations. idf
      recommends a maximum 6.5 % HbA1c concentration for all diabetic patients - 7.0 % for type II
      diabetes mellitus (dm-ii) patients - and, the closer to this value, the fewer risk of
      complications. The American Diabetes Association (ADA) recommends at least two HbA1c measures
      per year in controlled patients and three times per year in patients with therapeutic changes
      and/ or failures.

      According with Sartore and collaborators, glucose variability indicators describe the glucose
      profile of diabetic patients and identify any worsening glycaemic control more accurately
      than HbA1c tests. However, the capillary glycaemic measure - the standard monitoring blood
      glucose (smbg) - has some issues that can compromise the optimal diabetes management: with
      smbg, blood glucose measures are more intermittent, are insufficient to evaluate the
      glycaemic profile of the patient, and it does not show what happens between two measurements.
      This situation makes it difficult to interpret and extrapolate information necessary to make
      adequate decisions in the therapeutic adjustments.

      Another clinical important issue is concerned with hypoglycaemia. Hypoglycaemia events limit
      the efficacy of intensive insulin therapy, especially in patients with great glucose
      variability, and are associated with increased risk of diabetic complications and
      cardiovascular disease. The smbg ideal frequency is difficult to establish and consequently,
      hypo and hyperglycaemic events may be underestimated, even when the measurements and done
      more frequently than recommended. This underestimation of glucose fluctuations may constitute
      a critical problem as they have a potential important role in the long term complications
      occurrence. Several studies report the efficacy of using a professional continuous glucose
      monitoring (pCGM) device on the detection and reduction of hypoglycaemia and on the detection
      of hyperglycaemia, alone or compared with SMBG.

      Another important parameter is the area under the curve (AUC) in hypoglycaemia, that is,
      taking into account not only the duration of the events but also its severity.

      This information may be crucial for the provider to make clinical decisions and perform
      therapeutic adjustment in order to control glucose levels more efficiently. Additionally,
      with a better control of the disease, fewer events are expected to occur showing not only a
      better clinical situation but also economic benefits of the pCGM over the SMBG alone.

      The iPro2 is a pCGM device (from Medtronic Minimed, Northridge, CA) intended to continuously
      record interstitial glucose levels in persons with dm. It is also intended to be worn for
      intermittent periods to uncover glycaemic variability and patterns. The data obtained can
      then be used to maximize treatment strategies to improve patient outcomes.

      The study's primary objective is to compare the difference in mean glycated haemoglobin level
      after clinical decision on diabetes treatment based on pCGM.
    

Intervention name(s): Continuous Glucose Monitoring (CGM)
Intervention type(s): Device
Intervention description(s): On each visit (baseline, 4, 8, and 12 months), participants received an iPro2 CGM device (MiniMed Medtronic), placed according to the manufacturer's standard procedure. The iPro2 was used each time for 7-days. During this period, patients were asked to perform 4 SMBG measurements daily for calibration (fasting, lunch, dinner, and before bed). Patients received a diary to register food intake, physical activity and medication, SMBG values, and any diabetes-related event (extra consultations, phone calls, etc) in the previous 4 months.
Each time, CGM data was interpreted by an expert clinician, and a report was delivered, within one week, to the respective healthcare team. This report was discussed together by the patient and one member of the healthcare team, either in consultation or by phone, agreeing on any necessary therapeutic changes. If necessary, extra consultations for nutrition, nursing, or education, were scheduled, to address specific needs identified during rCGM review.
Intervention model: Single Group Assignment
Intervention model description: Evaluation of clinical outcomes and patient reported outcomes
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: continuous glucose monitoring