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Professional CGM

Implementing PROFESSIONAL CGM

PROFESSIONAL CGM IS RECOMMENDED BY CLINICAL GUIDELINES

Professional CGM is a powerful tool for exploring a wide range of clinical situations in patients with diabetes…the main benefits of retro CGM come from the decisions taken and agreed upon by the healthcare team and the patient, as well as from their implementation.1

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Retrospective or diagnostic use of CGM may be useful in patients with suspected non-diabetic glucidic abnormalities (hypoglycemia syndromes, glycogenosic, cystic fibrosis) or in diabetic gastroparesis syndromes. Pro CGM can be used with type 1 patients to evaluate the glycemic profile and optimize the insulin therapy or in type 2 patients fragile and / or unstable.2

…Several small-scale studies have shown that professional CGM can lead to reductions in A1C, weight loss, and/or reductions in incidence of hypoglycemia in patients with type 2 diabetes when the clinician uses the data to guide therapeutic changes.3

HbA1C may underestimate or overestimate the mean glucose, thus a patient’s CGM profile has considerable potential for optimizing his or her glycemic management…CGM are essential tools to assess therapy and detect incipient hypoglycemia. Hypoglycemia may increase the risk of harm to self or others, such as with driving.4

FRENCH POSITION STATEMENT1

THE TWO MAIN INDICATIONS FOR RETRO CGM ARE:

  • Patients with HbA1c levels above target
    • Night-time/early-morning (on awakening) hyperglycaemia
    • Postprandial hyperglycaemia
    • Late-afternoon hyperglycaemia
  • Patients unaware of or suspected of having frequent/severe hypoglycaemia
    • Detection of silent nocturnal hypoglycaemia
    • Analysis of hypoglycaemia schedule, pattern, causes
    • Detection of hypoglycaemia unawareness

MISCELLANEOUS INDICATIONS:

  • Brittle diabetes (variability analysis, assessment of potential causes)
  • Flexible insulin therapy (FIT; assessment of FIT algorithms)
  • Physical activity (glycemic effect of activity, validation of therapeutic actions to avoid hypoglycaemia during physical activity)
  • Pregnancy (optimalization of glycemic control)
  • Discrepancy between HbA1c and self-monitored blood glucose (underestimation of HbA1c in dialysis patients, low/high haemoglobinglycation phenotypes)
  • Specific/difficult clinical situations leading to variable glucose patterns (such as chronic dialysis, shift-work schedules and defective compliance)

USE CASES Сould be used for individuals with diabetes that is not using Personal CGM and based on the below use cases.
*The Envision™ Pro is indicated for ages 14 and above.

HCP OBJECTIVE

  • Therapy optimization5
    • Intensify
    • De-intensify
    • Fine-tuning
  • New Patient Evaluation
  • Educational Tool
  • Before / after bariatric surgery
  • Clinical trials

Patient profile

  • Individuals with type 1 or type 2 diabetes* with any of the following attributes
    • Less tech-savvy
    • Non-intensive therapy
    • Overwhelmed by data, alarms
    • Want minimal intervention during the evaluation
    • Cannot afford Personal CGM

*The Envision™ Pro is indicated for ages 14 and above.

INTERPRETATION

3 STEP METHODOLOGY TO INTERPRET CARELINK™ FOR PROFESSIONAL CGM

This guide is intended to provide healthcare professionals a simple 3 Step Methodology to interpret Carelink™ for Professional CGM reports.

You may use the information in the report to adjust therapies and/or suggest lifestyle changes for your patients.

RECOMMENDATION: MAKE 1-2 ADJUSTMENTS AT A TIME.

3 Simple steps Within each step, assess for hypoglycemia, then hyperglycemia

  • 1. Evaluate overnight (12 Am – 6 AM)
  • 2. Evaluate preprandial (before meals)
  • 3. Evaluate postprandial (2–3 hours after meals)

5 Simple reports

ISTANTANEA DEGLI ANDAMENTI ISTANTANEA DEGLI ANDAMENTI

Summary report to identify challenges and potential causes

DAILY OVERLAY DAILY OVERLAY

Quick Review of Glucose Excursions/Trends

OVERLAY BY MEAL OVERLAY BY MEAL

Close Examination of 3 Critical Periods

DAILY SUMMARY DAILY SUMMARY

Help Identify Cause and Effect

PATIENT NOTES PATIENT NOTES

Detailed Notes input via Envision™ Pro App or manual entry

REPORTS CAN BE REVIEWED IN THE FOLLOWING ORDER:

1. HIGH LEVEL REVIEW: Pattern Snapshot to quickly see glycemic control metrics & overview of challenges and potential solutions

2. DETAILED REVIEW: Use Daily Overlay and Overlay by Meal reports by time period to optimize therapy

3. SUPPLEMENT: Your interpretation with Daily Summary Report and Patient Notes to identity the cause and effect of glucose trends

STEP 1: OVERNIGHT PERIOD
(12AM – 6 AM)

PATTERN SNAPHOT

PATTERN SNAPHOT

DAILY OVERLAY

DAILY OVERLAY

OVERLAY BY MEAL

OVERLAY BY MEAL

Night Time Sensor Data (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • DOSE OF ORAL MEDICATION MAY BE TOO HIGH
    • Decrease dose of oral medication which may affect nocturnal glucose
  • BASAL RATE OR LONG ACTING BASAL INSULIN MAY BE TOO HIGH
    • Decrease basal rate on insulin pump at night or basal insulin dose
  • PRIOR EVENING EXERCISE OR PHYSICAL ACTIVITY
    • Decrease dose of oral medication or insulin which may affect nocturnal glucose
    • Decrease basal rate with use of temp basal feature on insulin pump at night
    • Educate patient on effects of exercise on glucose
  • PRIOR EVENING ALCOHOL USE
    • Educate patient on effects of alcohol use on glucose

Night Time Sensor Data (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • DOSE OF ORAL MEDICATION MAY BE TOO HIGH
    • Decrease dose of oral medication which may affect nocturnal glucose
  • BASAL RATE OR LONG ACTING BASAL INSULIN MAY BE TOO HIGH
    • Decrease basal rate on insulin pump at night or basal insulin dose
  • FASTING
    • Decrease basal rate on insulin pump at night or basal insulin dose during periods of fasting

Night Time Sensor Data (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • LATE EVENING SNACK/DINNER OR LARGER DINNER WITH HIGH FAT CONTENT
    • Evaluate previous evening meal (i.e. fat and quantity) and dinner insulin bolus
    • If on insulin pump, consider dual wave bolus
  • INADEQUATE DOSE OF ORAL MEDICATION
    • Increase dose of oral medication which would affect fasting glucose
  • INADEQUATE BASAL RATE OR LONG ACTING BASAL INSULIN
    • Increase basal rate on insulin pump at night or basal insulin dose

Night Time Sensor Data (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • DOSE OF ORAL MEDICATION MAY BE TOO HIGH
    • Decrease dose of oral medication which may affect nocturnal glucose
  • BASAL RATE OR LONG ACTING BASAL INSULIN MAY BE TOO HIGH
    • Decrease basal rate on insulin pump at night or basal insulin dose
  • PRIOR EVENING EXERCISE OR PHYSICAL ACTIVITY
    • Decrease dose of oral medication or insulin which may affect nocturnal glucose
    • Decrease basal rate with use of temp basal feature on insulin pump at night
    • Educate patient on effects of exercise on glucose
  • PRIOR EVENING ALCOHOL USE
    • Educate patient on effects of alcohol use on glucose

STEP 2: PRE-PRANDIAL PERIODS
(BREAKFAST > LUNCH > DINNER)

PATTERN SNAPHOT

PATTERN SNAPHOT

DAILY OVERLAY

DAILY OVERLAY

OVERLAY BY MEAL

OVERLAY BY MEAL

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • DOSE OF ORAL MEDICATION MAY BE TOO HIGH
    • Decrease dose of oral medication which would affect pre-meal glucose
  • BASAL RATE OR LONG ACTING BASAL INSULIN MAY BE TOO HIGH
    • Decrease basal rate on insulin pump prior to meal or basal insulin dose
  • INSULIN BOLUS WITH LAST MEAL MAY BE TOO HIGH
    • Decrease insulin bolus with prior meal
  • EXERCISE OR PHYSICAL ACTIVITY
    • Decrease dose of oral medication or insulin
    • Decrease basal rate with use of temp basal feature on insulin pump
    • Educate patient on effects of exercise on glucose
    • Review previous meal (Use “Daily Summary” and “Patient Notes”)

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • INADEQUATE BASAL RATE OR LONG ACTING BASAL INSULIN
    • Increase basal rate prior to observed hyperglycemia period or basal insulin dose
  • INADEQUATE INSULIN BOLUS FROM LAST MEAL
    • Increase insulin bolus with prior meal
  • INADEQUATE DOSE OF ORAL MEDICATION
    • Increase dose of oral medication which would affect pre-meal glucose
    • Connect behavior and medication with excursion (Use “Daily Summary”and “Patient Notes”)

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • VARIABLE EXERCISE PATTERN
    • Use standardized exercise time/ intensity prior to meal to test glycemic response
  • NON COMPLIANT TO ORAL OR INSULIN REGIMEN
    • Educate patient on compliance
    • Review excursions for specific days to better understand the relationship between activity and glucose control (Use “Daily Summary” and “Patient Notes”)

STEP 3: POST-PRANDIAL PERIODS
(BREAKFAST > LUNCH > DINNER)

PATTERN SNAPHOT

PATTERN SNAPHOT

DAILY OVERLAY

DAILY OVERLAY

OVERLAY BY MEAL

OVERLAY BY MEAL

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • DOSE OF ORAL MEDICATION MAY BE TOO HIGH
    • Decrease dose of oral medication which would affect post-prandial glucose
  • PRE-MEAL BOLUS MAY BE TOO HIGH
    • Decrease pre-meal insulin bolus which would affect post-prandial glucose
  • PRIOR EXERCISE OR PHYSICAL ACTIVITY
    • Decrease dose of oral medication or insulin which may affect nocturnal glucose
    • Decrease basal rate with use of temp basal feature on insulin pump at night
    • Educate patient on effects of exercise on glucose
  • DELAYED FOOD ABSORPTION
    • Review previous meal (Use “Daily Summary” and “Patient Notes”)

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • INADEQUATE DOSE OF ORAL MEDICATION
    • Increase dose of oral medication which would affect post-prandial glucose
  • INADEQUATE PRE-MEAL BOLUS (THIS COULD INCLUDE AN INADEQUATE DOSE OF CORRECTION INSULIN)
    • Increase pre-meal insulin bolus

Overlay by Meal Event (mg/dL)

 

POTENTIAL CAUSES FOR THERAPY CONSIDERATION

  • VARIABLE MEAL COMPOSITION AND QUANTITY
    • Use standardized known carb, low fat meal to test glycemic response
    • Count carbohydrates, if on insulin with meals
  • VARIABLE EXERCISE PATTERN
    • Use standardized exercise time/intensity to test glycemic response
  • NON COMPLIANT TO ORAL OR INSULIN REGIMEN
    • Educate patient on compliance
    • Review excursions for specific days to better understand the relationship between activity and glucose control (Use “Daily Summary” and “Patient Notes”)

PATIENT CASE STUDIES** Case studies represent real patient information. The CGM device that was used for the evaluations is iPro™ 2 Professional CGM.

CASE STUDY 1: T1

  • PATIENT INFORMATION: Type 1 diabetes
  • A1C: 8.5%
  • MEDICATION Slow-acting insulin analogue in the evening, rapid-acting insulin analogue in the morning and evening and 70 premix at midday.
  • BRIEF BACKGROUND: Not available

QUESTION:
How can the variability in the patient’s blood glucose levels be reduced?

1ST PROFESSIONAL CGM EVALUATION:

ANALYSIS:

THERAPY CHANGE:
Increase the premix at midday and reduce the basal rate.

2ND PROFESSIONAL CGM EVALUATION:

ANALYSIS:
HbA1c reduced to 7.8% and reduced variability in blood glucose levels. Recording made it possible to reassess the therapy regimen.

FINAL OUTCOME:Limit the continuing night-time hypoglycaemic episodes.

CASE STUDY 2: T1 AND PREGNANCY

  • PATIENT INFORMATION: Type 1 diabetes, pregnant.
  • A1C: HbA1c decreased from 9%, four months ago, to 7.4% However, the patient is a little disappointed.
  • MEDICATION Intensive regimen: 5 injections per day and SMBG four times a day.
  • BRIEF BACKGROUND: 1st pregnancy unplanned, HbA1c = 12%; emergency delivery at 35 weeks due to foetal distress. The infant was born weighing 3.870kg and is currently in very good health.

QUESTION:
How can Mrs SG’s treatment best be adjusted? Are the night-time hypoglycaemic episodes that Mrs SG reports actually confirmed?

1ST PROFESSIONAL CGM EVALUATION:

ANALYSIS:
High degree of variability in blood glucose levels from day to day. Nighttime hypoglycaemic episodes and postprandial hyperglycaemic episodes.

THERAPY CHANGE:
Increase the frequency of the capillary blood glucose tests to 6 times a day to cover all post-prandial periods. Reeducate the patient regarding the carbohydrate content of foods to improve the reproducibility of post-prandial blood glucose levels. Fit an insulin pump.

2ND PROFESSIONAL CGM EVALUATION:

ANALYSIS:
A very clear improvement in the overall balance and variability of blood glucose levels. Persistence of some nighttime hypoglycaemic episodes and some post-prandial hyperglycaemic episodes. HbA1c of approximately 6%.

THERAPY CHANGE:
Reduce the night-time basal rate to eliminate hypoglycaemic episodes and continue to work on meal contents.

FINAL OUTCOME: The patient’s baby was born by elective caesarian after 38 weeks of amenorrhoea. Patient A gave birth to a healthy little girl weighing 3kg.

CASE STUDY 3: T2 NEWLY DIAGNOSED

  • PATIENT INFORMATION: Male, 63 years old type 2 diabetes diagnosed 2 months ago.
  • A1C: N/A
  • MEDICATION: Glargine
  • BRIEF BACKGROUND: Patient was initially prescribed insulin for glucose control but he then complained that the insulin caused him to not feel good. The patient made the decision to discontinue using the insulin.

QUESTION:
The patient had discontinued using his previously prescribed insulin. He complained that it made him feel as if he was fluctuating between low and high glucose episodes. The patient is now noticing that his glucose readings are always over 200 and he has feelings of fatigue, increased appetite and also nausea. What regimen will work best to keep this patient within target range so he can avoid fluctuations?

1ST PROFESSIONAL CGM EVALUATION:

ANALYSIS:
Persistent hyperglycemia is seen throughout the day. The current regimen is not working for this patient.

THERAPY CHANGE:
Glargine was discontinued and a low dose of Tresiba® and Humalog® was prescribed.

2ND PROFESSIONAL CGM EVALUATION:

ANALYSIS:
The patient has better glucose control overall after making therapy adjustments and time in range was 84%. These results were seen two months later after the first evaluation.

FINAL OUTCOME: Marked improvement was seen in overall glycemic control, without any increase in hypoglycemia.

CASE STUDY 4: T2 BASAL INSULIN, ORAL MEDICATION

  • PATIENT INFORMATION: Female, 89 years of age type 2 diabetes diagnosed >12 years ago.
  • A1C: 7.4%
  • MEDICATION: Lantus ® , Glipizide, Lasix, Zyloprim, Norvasc, Zocor, Toprol, Levothyroxine.
  • BRIEF BACKGROUND: This patient has been struggling to manage her type 2 diabetes for well over 12 years. Secondary complications have developed (neuropathy and nephropathy).

QUESTION:
The patient is complaining of chronic fatigue and is noticing higher glucose readings throughout the day. Is there a certain time, specific activity or food that is causing these high glucose episodes? What can be adjusted with her medication to help minimize hyperglycemia?

1ST PROFESSIONAL CGM EVALUATION:

ANALYSIS:
The patient has consistent hyperglycemia after meals. The Professional CGM evaluation revealed that the patient was in hyperglycemia 80% of the time.

THERAPY CHANGE:
Lantus® basal insulin was increased and Acarbose was added before meals to provide more control at mealtime.

2ND PROFESSIONAL CGM EVALUATION:

ANALYSIS:
Glucose numbers are now more stable and post meal glucose levels are more controlled.

FINAL OUTCOME: Patient had an A1C of 6.6% a few months after the first Professional CGM evaluation and medication adjustments.

CASE STUDY 5: T2 MIXED INSULIN, ORAL MEDICATION

  • PATIENT INFORMATION: Male, 57 years old type 2 diabetes diagnosed 10 years ago.
  • A1C: 9.3%
  • MEDICATION: Humalog ® (50/50) mix, glyburide, Metformin, Tribenzor ® , Bystolic ® .
  • BRIEF BACKGROUND: Patient has peripheral neuropathy, nephropathy with microalbuminuria, popliteal disease, had a recent arterial stent inserted and also has small vessel disease. He has been on insulin for 4 years. The patient had challenges with committing to follow-up clinic appointments and struggled with adhering to taking the prescribed medication dosage.

QUESTION:
How can this patient have better glucose control without increasing low blood sugar episodes? The patient states he feels fine but has fluctuating glucose levels and wants better control but does not like the feeling of having low blood sugars.

1ST PROFESSIONAL CGM EVALUATION:

ANALYSIS:
Need for additional basal and bolus control. Adding a GLP1 will also likely help.

THERAPY CHANGE:
Add Bydureon®, adjust Humalog® (50/50) mix, and add Crestor (rosuvastatin calcium).

2ND PROFESSIONAL CGM EVALUATION:

ANALYSIS:
Much better control seen with only periodic glucose elevations with a reduction in A1C to 8.3%.

FINAL OUTCOME: Patient was able to effectively lower his A1C while not increasing low glucose episodes. Shortly after the second evaluation the patient saw continued success with adjustments and had an A1C of 7.1%.

Attachment

Resources

Envision™ PRO Patient Quick Reference Guide

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Envision™ PRO HCP Quick Reference Guide

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Envision™ PRO One Pager

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Envision™ PRO Patient Brochure

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