Memorandum

Endocrine Society publishes very positive CGM and pump Clinical Practice Guideline for adults with diabetes – September 27, 2016

Executive Highlights

  • Yesterday, the Endocrine Society announced a new Clinical Practice Guideline (published in JCEM) regarding use of pumps and CGM in adults with diabetes. The authors include Dr. Anne Peters (chair), Dr. Andrew Ahmann, Dr. Tadej Battelino, Ms. Alison Evert, Dr. Irl Hirsch, and Dr. Howard Wolpert. What a powerhouse group – and one that is renowned for sharing patient perspectives.
  • CGM received the highest grade in the guideline - a “1” recommendation with “high quality” evidence – and is recommended in adults with type 1 diabetes regardless of A1c level. As expected, patients must be willing and able to use CGM devices nearly daily, and there is a major focus on adequate provider education and patient selection. We see the very strong recommendation as a major win for the field, and hopefully it will bode positively for the payer landscape.
  • Evidence for pumps over MDI was actually ranked a bit lower than CGM (“moderate” and “low quality” evidence), but also received a broad recommendation – pumps are recommended for adults with type 1 who are not at A1c goal; those experiencing severe hypoglycemia or high glycemic variability; and patients desiring greater flexibility.
  • The Guideline “suggests” use of pumps and intermittent CGM in type 2 diabetes, though the evidence is poor in both cases (“low quality”). Abbott’s FreeStyle Libre is not included in the recommendations.

Yesterday, the Endocrine Society announced a new, very positive Clinical Practice Guideline published in JCEM and focused on pumps and CGM in adults with diabetes (11.5 pages, 119 citations). The all-star author lineup includes Dr. Anne Peters (chair), Dr. Andrew Ahmann, Dr. Tadej Battelino, Ms. Alison Evert, Dr. Irl Hirsch, and Dr. Howard Wolpert.

Notably, CGM received the highest grade in the guideline  - a “1” recommendation with “high quality” evidence – and is recommended in adults with type 1 diabetes regardless of A1c level. Yes! We loved the strong first line of the Endocrine Society press release, which calls for CGM “as the gold standard of care for adults with type 1 diabetes.” The Guideline does it make it clear, of course, that patients must be “willing and able” to use CGM and wear it nearly daily.

Notably, evidence for pumps over MDI was ranked a bit lower than CGM (a “1” but with “moderate” and “low quality” evidence), though it also received a very broad recommendation: adults with type 1 who are not at A1c goal; those experiencing severe hypoglycemia or high glycemic variability; and patients desiring greater flexibility. We were surprised, however, to see how much of the evidence for pumps is either weak or low quality.  

The Guideline “suggests” use of pumps and intermittent CGM in type 2 diabetes, though the evidence is rated much weaker (“low quality”). We hope this improves as CGM and pumps become ready for prime time in type 2 – to date they have not been easy enough to use or reimbursed well enough. Of course, studies are also sorely lacking in this population.

The Guideline explicitly excludes FreeStyle Libre (“does not provide true CGM in terms of providing alerts”) and does not include results from Dexcom’s DIaMonD study testing CGM in MDIs (presented at ADA, but awaiting publication). DIaMonD is mentioned in two places in the article, which the authors argue will provide “conclusive” evidence on the benefits of CGM in MDIs (both type 1 and type 2). As a reminder, only type 1 data was presented at ADA.

Notably, the Guideline is jointly endorsed by AADE, the European Society for Endocrinology, and AACC. We hope this paper bodes well for private and public payer coverage of CGM, which must get better if this market has any chance of expanding dramatically. Though many cite 95%+ private payer coverage of CGM in the US, we continue to hear CGM is too expensive or too hard to access for many people with diabetes. 

  • The authors cautiously touch on automated insulin delivery in the last section, only noting that it is “promising” but too early to grade the evidence. They conclude with a very key point: “To realize large-scale and long-term use of these devices, we need a better understanding of the catheter and site problems common with CSII and RT-CGM and appropriate cost-benefit analysis when compared to current therapies.”
  • It feels like the CGM field is maturing – better products, greater competition, larger outcome studies (DIaMonD, REPLACE, IMPACT) and stronger Guideline recommendations like this one. Is the field at an inflection point? Our soon-to-be-published 1Q16/2Q16 Industry Roundup actually suggests CGM industry sales (Dexcom + estimated Medtronic) may come close to $1 billion this year! This does not include Abbott’s FreeStyle Libre, which has 125,000+ users in Europe (revenue backing out to roughly $45 million in 2Q16, assuming all patients are using two sensors per month).

Summary of Clinical Practice Guideline Recommendations

  • Strong recommendations use the phrase “we recommend” and the number 1, and weak recommendations use the phrase “we suggest” and the number 2. The Guideline also rates the quality of the evidence, such that: very low quality evidence (one circle); low quality evidence (two circles); moderate quality evidence (three circles); and high quality evidence (Four circles). We summarize the topline recommendations below. 

CGM Recommendations

Recommendation Strength / Evidence Quality

Type 1 diabetes (A1c above target): We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM who have A1C levels above target and who are willing and able to use these devices on a nearly daily basis.

Strong

“High Quality” Evidence

Type 1 diabetes (well-controlled): We recommend RT-CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on a nearly daily basis.

Strong

“High Quality” Evidence

Type 2 diabetes: We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C levels >7% and are willing and able to use the device.

Weak

“Low Quality” Evidence

 

Pump Recommendations

Recommendation Strength / Evidence Quality

Type 1 Diabetes (A1c above target): We recommend continuous subcutaneous insulin infusion (CSII) over analog-based basal-bolus multiple daily injections (MDI) in patients with type 1 diabetes mellitus (T1DM) who have not achieved their A1C goal, as long as the patient and caregivers are willing and able to use the device.

Strong

“Moderate Quality” Evidence

Type 1 Diabetes (hypoglycemia, variability): We recommend CSII over analog-based basal-bolus MDI in patients with T1DM who have achieved their A1C goal but continue to experience severe hypoglycemia or high glucose variability, as long as the patient and care- givers are willing and able to use the device.

Strong

“Low Quality” Evidence

Type 1 Diabetes (flexibility): We suggest CSII in patients with T1DM who require increased insulin delivery flexibility or improved satisfaction and are capable of using the device

Weak

“Low Quality” Evidence

Type 2 Diabetes: We suggest CSII with good adherence to monitoring and dosing in patients with type 2 diabetes mellitus (T2DM) who have poor glycemic control despite intensive insulin therapy, oral agents, other injectable therapy, and lifestyle modifications.

Weak

“Low Quality” Evidence

 

Hospital Use: We suggest that clinicians continue CSII in patients admitted to the hospital with either type of diabetes if the institution has clear protocols for evaluating patients as suitable candidates and appropriate monitoring and safety procedures.

Weak

“Low Quality” Evidence

Selection of Candidates: We recommend that before prescribing CSII, clinicians perform a structured assessment of a patient’s mental and psychological status, prior adherence with diabetes self-care measures, willingness and interest in trying the device, and availability for the required follow-up visits.

Strong

“Low Quality” Evidence

Bolus Calculators: We suggest encouraging patients to use appropriately adjusted embedded bolus calculators in CSII and have appropriate education regarding their use and limitations

Weak

“Low Quality” Evidence

 

Summary of Ungraded Good Practice Statement

Education and Training: We suggest that adults with T1DM and T2DM who use CSII and continuous glucose monitoring (CGM) receive education, training, and ongoing support to help achieve and maintain individualized glycemic goals.

  • The three concluding tables (see below) provide considerations for pump and CGM education/training, which reiterate how much work it is for HCPs to prescribe diabetes technology. We hope industry and great training materials (in-app, video, Skype) can shoulder more of this burden – prescribing these devices must get easier.

-- by Adam Brown and Kelly Close