Understanding Artificial Pancreas Systems: Results from a 24-Month Trial

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Open-label or unblinded (moderate): Open-label design

Industry funded (moderate): Industry funding reported

{"intervention_arm_id":"arm_1","reference_arm_ids":["arm_2"],"comparison_type":"between_group"}

Change in HbA1c from baseline was -0.79 in the control arm and -0.75 in the intervention arm (difference:+0.04, 95%CI: -0.22, 0.30).

HbA1c decreased in both groups, but the intervention did not improve HbA1c compared with usual care in the main randomized analysis.

Mean adherence during follow-up was 66.2% for usual care and 67.5% for intervention, resulting in no significant between-group differences (1.25%, 95%CI: -2.2%, 4.7%).

Medication adherence during follow-up was similar between usual care and intervention groups, with no meaningful between-group difference.

A pharmacist-delivered telephone intervention combining brief negotiated interviewing and shared decision-making to identify barriers, goals, and diabetes management strategies.

Positive: 0; Negative: 0; No effect: 2; Mixed: 0

Extracted 2 outcome signals across the study

The primary HbA1c outcome and medication adherence secondary outcomes showed no meaningful benefit in the randomized analysis.

HbA1c ↓ similarly in both groups, with no added benefit from intervention in the main randomized analysis

Medication adherence ↔ showed no meaningful between-group difference

Mostly intermediate or surrogate outcomes

The trial randomized 1,400 adults with poorly controlled type 2 diabetes in a 1:1 ratio.

The primary 12-month HbA1c difference was +0.04 percentage points for intervention versus usual care.

Only 202 intervention-arm participants completed an initial pharmacist consultation.

Lauffenburger JC, Ghazinouri R, Jan S, et al. Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENGAGE-DM pragmatic randomized trial. PLOS ONE. 2019;14(4):e0214754. doi:10.1371/journal.pone.0214754

Open-label behavioral intervention with patients and pharmacists aware of assignment.

Follow-up HbA1c values were missing for about 29% of participants and imputed.

Only about 30% of intervention participants completed the first consultation.

Adherence was measured indirectly using pharmacy claims.

In adults with poorly controlled type 2 diabetes, a telephone pharmacist intervention did not improve HbA1c or medication adherence compared with usual care.

As-treated HbA1c ↓ more among those who received the consultation, but this analysis is less definitive

The intervention was delivered over the telephone by a clinical pharmacist and consisted of a 2-step process integrating brief negotiated interviewing and shared decision-making.

Telephone-based pharmacist-delivered patient-centered intervention

Patients randomized to the usual care arm were not contacted in any way.

Usual care

Limited safety reporting (moderate): Safety reporting depth: not_reported

No post-intervention follow-up (moderate): 0 weeks of follow-up after treatment ended

Open-label or unblinded study (moderate): Open-label design

Telephone pharmacist coaching did not improve HbA1c in poorly controlled diabetes

This large pragmatic trial tested telephone coaching from clinical pharmacists for adults with poorly controlled type 2 diabetes. The program combined motivational interviewing and shared decision-making, but it did not improve HbA1c or medication adherence compared with usual care in the main analysis.

The main randomized result found no improvement compared with usual care.

As-treated results may be affected by differences between people who did and did not receive the intervention.

The intervention may not have matched patients’ main barriers, especially diet and exercise challenges.

Intervention	Outcome	Measured Change	Study Effect
Telephone-based pharmacist behavioral intervention (Behavioral & Lifestyle)	HbA1c (Glycemic Control)	Decrease	Limited
Telephone-based pharmacist behavioral intervention (Behavioral & Lifestyle)	Treatment adherence (Adherence & Engagement)	Uncertain	Limited

Telephone pharmacist coaching did not improve HbA1c in poorly controlled diabetes

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