Action Statement Profile KAS 2

Aggregate evidence qualityB (1 randomized controlled trial showing improved outcomes with metformin versus lifestyle combined with expert opinion).
BenefitLower HbA1c, target HbA1c sustained longer, less early deterioration of BG, less chance of weight gain, improved insulin sensitivity, improved lipid profile.
Harm (of using metformin)Gastrointestinal adverse effects or potential for lactic acidosis and vitamin B12 deficiency, cost of medications, cost to administer, need for additional instruction about medication, self-monitoring blood glucose (SMBG), perceived difficulty of insulin use, possible metabolic deterioration if T1DM is misdiagnosed and treated as T2DM, potential risk of lactic acidosis in the setting of ketosis or significant dehydration. It should be noted that there have been no cases reported of vitamin B12 deficiency or lactic acidosis with the use of metformin in children.
Benefits-harms assessmentPreponderance of benefit over harm.
Value judgmentsCommittee members valued faster achievement of BG control over not medicating children.
Role of patient preferencesModerate; precise implementation recommendations likely will be dictated by patient preferences regarding healthy nutrition, potential medication adverse reaction, exercise, and physical activity.
ExclusionsAlthough the recommendation to start metformin applies to all, certain children and adolescents with T2DM will not be able to tolerate metformin. In addition, certain older or more debilitated patients with T2DM may be restricted in the amount of moderate-to-vigorous exercise they can perform safely. Nevertheless, this recommendation applies to the vast majority of children and adolescents with T2DM.
Intentional vaguenessNone.
Policy levelStrong recommendation.