Dossier n. 247/2014 [Abstract] Self-monitoring blood glucose and insulin injection 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 to 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 Directorate General for Health and Social Policies of Emilia-Romagna Region to compare recommendations of international clinical practice guidelines - judged to be of good quality - addressing indication and management of devices for self-monitoring blood glucose and for insulin injection 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

Four guidelines were included: ADA, 2014; AMD-SID, 2014; CDA, 2013; NICE, 2010.

Self-monitoring blood glucose

Guidelines for self-monitoring blood glucose in children and adolescents with type 1 diabetes mellitus propose slightly different frequency and day scheduling patterns; the number of measurements per day ranges from 2 to 6. Three guidelines recommend meal/pre-prandial self-monitoring with the following distinctions: ADA 2014 prior to every snack, CDA 2013 also post-prandial, and NICE 2010 also at bedtime and occasionally at night-time. AMD-SID 2014 does not provide with a specific day schedule, however it specifically states the number of measurements per day and the number of blood glucose strips required per month: 6/8 measurements per day (250 strips per month) in subjects between 6 and 18 years of age, and up to 300 strips per month in subjects younger than 6 years. All guidelines agree in recommending to intensify monitoring prior to exercise, when low blood glucose is suspected, after treating low blood glucose up to normoglycemia, prior to critical tasks such as driving (adolescents) and in case of concomitant illness.

Insulin injection

All guidelines recommend basal-bolus regimen, but specification of minimum number of injections per day varies: at least 2 according to CDA 2012; at least 3 according to ADA 2014, not specified by AMD-SID 2014 and NICE 2010. One, two or three insulin injections per day (injections of short-acting insulin or rapid-acting insulin analogue mixed with intermediate-acting insulin) are also reported as suitable by NICE 2010.

Adults with type 1 diabetes mellitus

Four guidelines were included: ADA, 2014; AMD-SID, 2014; CDA, 2013; NICE, 2010.

Self-monitoring blood glucose

The four guidelines recommend numbers of measurements per day ranging from 3 to 6. Two guidelines (ADA, 2014; CDA, 2013) recommend meal/pre-prandial self-monitoring with the following distinctions: ADA 2014 also prior to every snack, and CDA 2013 also post-prandial. NICE 2010 does not provide specific scheduling but states that the optimal frequency of self-monitoring depends on the characteristics of an individual’s blood glucose control, the insulin treatment regimen, personal preferences. AMD-SID 2014 only specifies recommended number of measurements per day and number of blood glucose strips per month, without day schedule’s details: 4/5 measurements per day (150 strips per month), up to 200 strips per month at the start of treatment or in patients using insulin pump. Three guidelines agree in intensifying monitoring prior to exercise, when low blood glucose is suspected after treating low blood glucose up to normoglycemia, prior to critical tasks such as driving, in case of concomitant illness.

Insulin injection

All guidelines recommend basal-bolus regimen. Only ADA 2014 indicates 3 as the minimum number of injections per day. Twice-daily insulin regimen is also reported by NICE 2010 for adults who consider number of daily injections an important issue in quality of life.

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

Six guidelines were included: AMD-SID, 2014; CADTH, 2009; CDA, 2013; HAS, 2013; OSTEBA, 2012; SIGN, 2010.

Self-monitoring blood glucose

Four guidelines (AMD-SID, 2014; CADTH, 2009; CDA, 2013; SIGN, 2010) address self-monitoring blood glucose in women with gestational diabetes and the number of recommended measurements per day ranges from 3 to 8. AMD-SID 2014 recommends self-monitoring in all subjects, including those managed through diet; in treated subjects measurements are recommended prior and after meals and at night. The number of strips per months suggested ranges from 75 (only diet) to 250 (intensive insulin therapy). According to CADTH 2009 the optimal daily frequency of self-monitoring should be individualized; according to CDA 2013 self-monitoring should be carried out both fasting and post-prandially, to verify glycemic targets; according to SIGN 2010 only post-prandially.

Five guidelines (AMD-SID, 2014; CDA, 2013; HAS, 2013; OSTEBA, 2012; SIGN, 2010) address self-monitoring blood glucose in pregnant women with diabetes mellitus and the number of recommended measurement per day ranges from 3 to 9. AMD-SID 2014 recommends 4/8 measurements per day (prior and after meals and at night), corresponding to 250 strips per month. According to CDA 2013 self-monitoring should be carried out both fasting and post-prandially, to verify glycemic targets; OSTEBA 2012 recommends it at fasting, and both prior and post-prandially in case of intensive insulin therapy; SIGN 2010 recommends it only post-prandially; according to HAS 2013 self-monitoring is only generically recommended.

Insulin injection

Two guidelines (AMD-SID 2014, CDA 2013) report recommendations on insulin injection therapy in women with gestational diabetes or pregnant women with diabetes mellitus. Both guidelines recommend multiple injections regimen in women with gestational diabetes that do not achieve glycemic targets within 2 weeks from nutritional therapy alone. In pregnant women with diabetes mellitus intensive insulin therapy is recommended.

Adults with type 2 diabetes mellitus

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

Self-monitoring blood glucose

All guidelines recommend self-monitoring blood glucose for adults with type 2 diabetes mellitus when treated with insulin therapy. Some of them detail the circumstances in which monitoring is most useful: when suspecting low blood glucose, after treating low blood glucose up to normoglycemia, prior to critical tasks such as driving, to assess the efficacy of treatment or life styles, in case of concomitant illness. Four guidelines report scheduled monitoring (ADA, 2014; CADTH, 2009; CDA, 2013; ICSI, 2012) with measurements ranging from 2 to 3 per day. AMD-SID 2014 details the number of blood glucose strips per month: 40 strips in case of treatment with oral antihyperglycemic agents and basal insulin once per day, 75-100 strips in case of high risk of low blood glucose, 125 strips in case of basal-bolus insulin therapy.

For patients treated only with oral antihyperglycemic agents the majority of guidelines recommend self-monitoring blood glucose only under special conditions: risk of hypoglycemia (CAD, 2013; HAS, 2012; NICE, 2009; SIGN, 2010), poor glycemic control (CDA, 2013; ICSI, 2012; SIGN, 2010), to assess the efficacy of treatment or life styles (HAS, 2012; NICE, 2009; SIGN, 2010), in case of concomitant illness (HAS, 2012; NICE, 2009; SIGN, 2010), during treatment with steroids (HAS, 2012). AMD-SID 2014 recommends monitoring in educated patients that are actively involved in their treatment; the suggested number of blood glucose strips per month is 25-50 in case of treatment with only oral antihyperglycemic agents, and 50-100 in case of high risk of low blood glucose and of change in treatment. One guideline (CADTH, 2009) does not recommend self-monitoring.

Insulin injection

Five guidelines (ADA, 2014; AMD-SID, 2014; CDA, 2013; ICSI, 2012; NICE, 2009) agree in recommending insulin therapy when glycemic targets are not achieved with oral antihyperglycemic agents (specified by CDA 2013 - HbA1c ≥8.5%, NICE 2009 - HbA1c ≥7.5%, and AMD-SID 2014 - HbA1c ≥53 mmol/mol, equal to ≥7%). Three guidelines also recommend monitoring in case of symptomatic hyperglycemia (ADA, 2014; CDA, 2013; VA/DoD, 2010). Suggested regimens are NPH insulin injected once or twice daily (HAS, 2013; NICE, 2009; SIGN, 2010), or long-acting analogues (CDA 2013). Basal-bolus regimen is recommended when glycemic targets are not achieved (CDA 2013) or when flexibility to patient’s meal and activity schedules is needed. AMD-SID 2014 suggests various options (basal, twice injections, basal-bolus) depending on the glycemic control.