Dossier n. 248/2014 [Abstract] Devices for continuous glucose monitoring and continuous subcutaneous insulin infusion in patients with diabetes mellitus. Comparative summary of recommendations from clinical practice guidelines

BACKGROUND

Good quality clinical practice guidelines provide recommendations based on a systematic review of the evidence, an assessment of balance of benefits and harms, and a transparent process for translating evidence into recommendations. In last decades clinical practice guidelines production has spread among health agencies, governmental bodies, scientific societies, clinical experts. The availability of a high number of existing guidelines justifies their adaptation to the needs of local users as an alternative to de novo guideline development. Recommendations often differ among guidelines on the same topic so tools to compare and synthesize guidelines that address similar topic areas have been recently developed.

AIM

The Regional Agency for Health and Social Care received the mandate from the General Directorate for Health and Social Policies of Emilia-Romagna Region to compare recommendations of international clinical practice guidelines - judged to be of good quality - addressing management of continuous glucose monitoring, continuous subcutaneous insulin infusion, and sensor-augmented pump in the following group of outpatients:

• children and adolescents with type 1 diabetes mellitus;
• adults with type 1 diabetes mellitus;
• women with gestational diabetes or pregnant women with type 1 or type 2 diabetes mellitus;
• adults with type 2 diabetes mellitus

METHODS

The methodology applied to select and compare clinical practice guidelines is taken from the Banca Dati Comparativa del Sistema Nazionale Linee Guida (SNLG-ISS). A systematic search of clinical practice guidelines published from 2009 to 2014 was performed. Clinical practice guidelines were included on the basis of methodological quality, assessed through the AGREE II instrument. Each synthesis includes relevant recommendations extracted from the included guidelines, the corresponding grading of evidence and a brief discussion on areas of agreement or discrepancy.

RESULTS

Children and adolescents with type 1 diabetes mellitus

Eight guidelines were included: ADA, 2014; AMD-SID, 2014; AAP, 2013; APEG-ADS, 2011; CDA, 2013; NICE, 2010; OSTEBA, 2012; SIGN, 2010.

Continuous glucose monitoring

Three guidelines (ADA, 2014; APEG-ADS, 2011; NICE, 2010) recommend continuous glucose monitoring for children and adolescents with type 1 diabetes mellitus only under specific conditions: ADA 2014 for subjects with hypoglycemia unawareness and/or frequent hypoglycemic episodes and with adherence to ongoing use of the device; APEG-ADS 2011 for those - supervised by specialist units - with hypoglycemia unawareness, recurrent severe hypoglycemia or suspected nocturnal hypoglycemia; NICE 2010 for subjects with persistent problems with hypoglycemia unawareness or repeated hypoglycemia or hyperglycemia; in this case patients should be offered blood glucose monitors with memories because these are associated with improved patient satisfaction. Another document (AMD-SID 2014) considers continuous glucose monitoring as useful for subjects with good compliance in use in order to achieve desired HbA1c levels and lower serious hypoglycemic events. One guideline (OSTEBA, 2012), while considering continuous glucose monitoring useful to improve or maintain metabolic control in patients motivated and trained in intensive care, does not recommend its “universal use”.

Continuous subcutaneous insulin infusion

Five guidelines (APEG-ADS, 2011; AMD-SID, 2014; NICE, 2010; OSTEBA, 2012; SIGN, 2010) recommend continuous subcutaneous insulin infusion for children and adolescents with type 1 diabetes mellitus with poor glycaemic control or disabling hypoglycemias, provided the support of a health team expert in this type of therapy is available. According to two of these guidelines (APEG-ADS, 2011; SIGN, 2010) this device is specially recommended for those with very low basal insulin requirements (i.e. infants and very young children). NICE 2010 and SIGN 2010 specify also minimal requirements for diabetic care team providing pumps. A sixth document (CDA, 2013) considers continuous subcutaneous insulin infusion therapy as an alternative to the increased frequency of injections or change in the type of basal and/or bolus insulin, when diabetic goals are not met. For ADA 2014 continuous subcutaneous insulin infusion therapy is an equal alternative to multi-daily insulin injections.

Sensor-augmented pump

Only two out of eight guidelines (ADA, 2014; AMD-SID, 2014) consider sensor-augmented pump therapy. Both suggest the use for patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness. In particular ADA 2014 refers to patients with type 1 diabetes mellitus of any age.

Adults with type 1 diabetes mellitus

Eight guidelines were included: ADA, 2014; AMD-SID, 2014; APEG-ADS, 2011; CDA, 2013; NICE, 2010; OSTEBA, 2012; SIGN, 2010; VA/DoD, 2010.

Continuous glucose monitoring

Two guidelines (ADA, 2014; APEG-ADS, 2011) recommend continuous glucose monitoring for adults with type 1 diabetes mellitus only under specific conditions: for subjects with frequent hypoglycemic episodes and with good adherence to ongoing use of the device, or in subjects aged more than 25 years to lower HbA1c (ADA, 2014). A third document (AMD-SID, 2014) recognizes usefulness for subjects aged more than 25 years to lower HbA1c. A last guideline (OSTEBA, 2012) acknowledges usefulness of continuous glucose monitoring to improve or maintain metabolic control in patients motivated and trained in intensive care, but does not recommend its “universal use”.

Continuous subcutaneous insulin infusion

Six guidelines (AMD-SID, 2014; APEG-ADS, 2011; NICE, 2010; OSTEBA, 2012; SIGN, 2010; VA/DoD, 2010) recommend continuous subcutaneous insulin infusion for adults with type 1 diabetes mellitus only under specific conditions. All guidelines agree - with slight differences - in recommending the use in case of poor glycemic control or of disabling hypoglycemias and provided the support of a health team expert in this type of therapy is available. In particular APEG-ADS 2011, NICE 2010, OSTEBA 2012 and VA/DoD 2010 underline the need to select patients with proved skills in mastering the device. A seventh document (CDA, 2013) considers continuous subcutaneous insulin infusion therapy as an alternative to the increased frequency of injections or change in the type of basal and/or bolus insulin, when diabetic goals are not met. For ADA 2014 continuous subcutaneous insulin infusion therapy is an equal alternative to multi-daily insulin injections.

Sensor-augmented pump

Only one out of eight guidelines (ADA, 2014) considers sensor-augmented pump therapy. The use is recommended for patients with frequent nocturnal hypoglycemia and/or hypoglycemia unawareness.

Women with gestational diabetes or pregnant women with type 1 or type 2 diabetes mellitus

Seven guidelines were included: ADA, 2014; AMD-SID, 2014; APEG-ADS, 2011; CDA, 2013; HAS, 2013; OSTEBA, 2012; SIGN, 2010.

Continuous glucose monitoring

AMD-SID 2014 considers continuous glucose monitoring - together with self-monitoring blood glucose - useful for pregnant women with type 1 diabetes and hypoglycemia unawareness. SIGN 2010 generically recommends continuous glucose monitoring for pregnant women with diabetes mellitus, without reporting any specific requirement.

No guideline considers continuous glucose monitoring for women with gestational diabetes.

Continuous subcutaneous insulin infusion

APEG-ADS 2011 recommends continuous subcutaneous insulin infusion for pregnant women with diabetes for whom the expected magnitude of benefit is clinically significant in terms of reducing HbA1c, reducing hypoglycemia or improving quality of life. OSTEBA 2012 recommends continuous subcutaneous insulin infusion when the desired HbA1c level has not been achieved, despite optimized treatment, for subjects with difficulties in managing hypoglycemia at the workplace, in order to improve the quality of life of patients. AMD-SID 2014 generically recommends continuous subcutaneous insulin infusion therapy as an alternative to standard therapy with insulin (basal-bolus, multi-daily insulin injections), without reporting any specific requirement.

No guideline considers continuous subcutaneous insulin infusion for women with gestational diabetes.

Sensor-augmented pump

No guideline considers sensor-augmented pump therapy for women with gestational diabetes or pregnant women with diabetes mellitus.

Adults with type 2 diabetes mellitus

Nine guidelines were included: ADA, 2014; AMD-SID, 2014; CDA, 2013; HAS, 2013; ICSI, 2012; NHMRC, 2009; NICE, 2009; SIGN, 2010; VA/DoD, 2010.

Continuous glucose monitoring

No guideline considers continuous glucose monitoring for adults with type 2 diabetes mellitus.

Continuous subcutaneous insulin infusion

ICSI 2012 suggests continuous subcutaneous insulin infusion for patients who require more intensified management of blood glucose and want more flexibility, or if pregnancy is planned. VA/DoD 2010 recommends not to consider continuous subcutaneous insulin infusion in most patients with type 2 diabetes mellitus.

Sensor-augmented pump

No guideline considers sensor-augmented pump therapy for adults with type 2 diabetes mellitus.