Efficacy of a glucose meter connected to a mobile app on glycemic control and adherence to self-care tasks in patients with T1DM and LADA: a parallel-group, open-label, clinical treatment trial

Oliveira, Felipe Martins de; Calliari, Luís Eduardo Procópio; Feder, Cecília Kauffman Rutenberg; Almeida, Maria Fernanda Ozorio de; Pereira, Mariana Vilela; Alves, Maria Thereza Teixeira de Almeida Fagundes; Garcia, Sônia Aparecida Dias; Reis, Ligia Dinara Donizeti; Salles, João Eduardo Nunes

doi:10.20945/2359-3997000000334

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Original Article • Arch. Endocrinol. Metab. 65 (2) • Mar-Apr 2021 • https://doi.org/10.20945/2359-3997000000334 copy

Efficacy of a glucose meter connected to a mobile app on glycemic control and adherence to self-care tasks in patients with T1DM and LADA: a parallel-group, open-label, clinical treatment trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

The main aim of the study was to evaluate the patients’ glycemic control and adherence to self-care tasks.

Materials and methods:

Patients with type 1 diabetes mellitus (T1DM) or latent autoimmune diabetes of the adult (LADA) using a multiple daily injection (MDI) regimen with carbohydrate counting (n = 25, Subgroup B) or fixed insulin dose (n = 25, Subgroup C) were allocated to use the application (app) for 12 weeks. Both subgroups were compared with each other and against a control group (n = 25, Group A) comprising patients with T1DM or LADA treated with continuous subcutaneous insulin infusion (CSII) in a parallel-group, open-label, clinical treatment trial. All patients had glycated hemoglobin (A1C) levels measured and were asked to fill out the Diabetes Self-Management Profile (DSMP) questionnaire at study start and end. The patients were instructed to measure capillary glucose six times daily in study weeks 4, 8, and 12.

Results:

Mean A1C levels decreased 0.725% in Subgroup C in intragroup analysis (p = 0.0063), and had a mean variation of 0.834% compared with Group A (p = 0.003). Mean DSMP scores increased 5.77 points in Subgroup B in intragroup analysis (p = 0.0004) and increased by a mean of 6.815 points in relation to Group A (p = 0.002).

Conclusion:

OneTouch Reveal improved both A1C levels and DSMP scores in patients with T1DM or LADA compared with standard treatment (CSII).

Keywords
Diabetes mellitus, type 1; glycated hemoglobin A; treatment adherence and compliance; self-management; blood glucose

Characteristics		Group A (n = 23)	Participants using OneTouch Reveal
Characteristics		Group A (n = 23)	Group B + C (n = 42)	Subgroup B (n = 22)	Subgroup C (n = 20)
Mean age (in years)		38.7	30.05	22.6	37.5
Sex, women/men (in %)		56.5/43.5	52.4/47.6	54.5/45.5	50/50
Mean age at diabetes diagnosis (in years)		20.7	17.3	11.3	23.3
Absolute number of patients with T1DM/LADA		19/4	38/4	22/0	16/4
Patients engaged in regular exercise (in %)		74	52.4	63.6	40
Mean weight (kg)		69.9	62.6	58.5	66.7
Mean body mass index (kg/m²)		25.7	23.7	22.8	24.6
Mean abdominal circumference (cm)		91.5	83.35	81.1	85.6
Patients according to education level (in %)	Incomplete elementary	4.34	9.52	4.54	15
	Complete elementary	None	7.14	9.09	5
	Incomplete secondary	None	4.76	4.54	5
	Complete secondary	43.4	42.8	45.4	40
	Incomplete higher	8.69	4.76	None	10
	Complete higher	34.78	26.2	31.81	20
	Postgraduate degree	8.69	4.76	4.54	5
Patients with microvascular complications (in %)	Retinopathy	13.04	11.9	4.54	15
	Nephropathy	13.04	14.3	None	30
	Neuropathy	17.39	19	9.1	30
Patients with positive diabetes autoantibodies (in %)	Anti-GAD	47.82	59.52	68.18	50
	Anti-islets	17.39	28.57	22.72	35
	Anti-insulin	13.04	11.9	13.63	10
Patients with other autoimmune diseases (in %)	Hashimoto's thyroiditis	39.13	30.95	45.45	15
Patients with other autoimmune diseases (in %)	Celiac disease	4.34	None	None	None
Types of insulin used (in %)	Aspart	100	85.7	86.4	85
	Lispro	None	14.3	13.6	15
	Detemir	None	38.1	40.9	35
	U 100 Glargine	None	33.4	40.9	25
	Degludec	None	28.5	18.2	40
Mean duration of carbohydrate counting or CSII treatment (in months)		29.13	Not applicable	24.9	Not applicable
Patients with macrovascular complications (in %)		None

Data				Group A (n = 23)	Participants using OneTouch Reveal
Data				Group A (n = 23)	Group B + C (n = 42)	Subgroup B (n = 22)	Subgroup C (n = 20)
Mean frequency of daily capillary blood glucose measurements (in number of measurements)
First FW				4.50	4.80	4.89	4.72
Third FW				4.67	4.67	4.66	4.68
(1)^* * P values of correlations between variations from the initial (first) to the final (third) focus week: (1) group A versus group B + C; (2) group A versus subgroup B; (3) group A versus subgroup C; (4) subgroup B versus subgroup C. Abbreviation: FW, focus week. p = 0.33, (2) p = 0.26, (3) p = 0.6, and (4) p = 0.62
Mean blood glucose levels (mg/dL)
First FW				171.89	171.01	177.60	164.42
Third FW				175.00	180.67	181.77	179.57
(1) p = 0.54, (2) p = 0.92, (3) p = 0.26, and (4) p = 0.42
Mean postprandial blood glucose levels (mg/dL)
First FW				176.01	180.13	188.00	172.27
Third FW				215.69	185.53	187.13	183.94
(1) p = 0.47, (2) p = 0.61, (3) p = 0.43, and (4) p = 0.76
Mean total daily insulin dose (in units)
First FW				44.40	54.55	56.30	52.80
Third FW				52.23	54.35	57.60	51.10
(1) p = 0.017, (2) p = 0.11, (3) p = 0.037, and (4) p = 0.33
Mean daily dose of bolus insulin (in units)
First FW				28.4	19.5	15.8	23.2
Third FW				27.9	18.9	17.4	20.5
(1) p = 0.94, (2) p = 0.38, (3) p = 0.42, and (4) p = 0.12
Rates of hyperglycemia (in %)
Total	First FW		39.27		38.49	40.40	36.29
Total	Third FW			42.32	44.39	45.18	43.47
(1) p = 0.71, (2) p = 0.66, (3) p = 0.86, and (4) p = 0.79
Level 1	First FW			23.88	20.41	20.92	19.82
Level 1	Third FW			26.76	23.09	25.24	20.60
(1) p = 0.2, (2) p = 0.65, (3) p = 0.08, and (4) p = 0.13
Level 2	First FW		15.38		18.08	19.47	16.46
Level 2	Third FW		15.55		21.30	19.94	22.87
(1) p = 0.19, (2) p = 0.36, (3) p = 0.17, and (4) p = 0.60
Rates of hypoglycemia (in %)
Total	First FW		4.36		8.66	6.81	10.51
Total	Third FW			3.79	8.20	6.33	10.07
(1) p = 0.009, (2) p = 0.09, (3) p = 0.004, and (4) p = 0.09
Level 1	First FW		3.39		5.12	4.27	5.97
Level 1	Third FW		3.22		5.34	3.65	7.03
(1) p = 0.04, (2) p = 0.41, (3) p = 0.007, and (4) p = 0.03
Level 2	First FW	0.97			3.54	2.55	4.54
Level 2	Third FW	0.57			2.86	2.69	3.04
(1) p = 0.02, (2) p = 0.06, (3) p = 0.02, and (4) p = 0.65
Level 3	None of the patients presented level 3 hypoglycemia throughout the study
Parameters of glycemic variability (% of patients within the indicated targets)
Patients with more than 70% of all blood glucose levels within 70–180 mg/dL (in %)	First FW			35	14	18	10
	(1) p = 0.05, (2) p = 0.21, (3) p = 0.05, and (4) p = 0.45
	Third FW			22	12	14	11
	(1) p = 0.31, (2) p = 0.47, (3) p = 0.33, and (4) p = 0.76
Patients with a coefficient of variation of glucose levels below 36% (in %)	First FW			61	21	23	20
	(1) p = 0.0014, (2) p = 0.009, (3) p = 0.006, and (4) p = 0.83
	Third FW			61	32	32	32
	(1) p = 0.02, (2) p = 0.05, (3) p = 0.06, and (4) p = 0.98
Patients with less than 4% of hypoglycemia (in %)	First FW			16	15	9	6
	(1) p = 0.011, (2) p = 0.05, (3) p = 0.01, and (4) p = 0.53
	Third FW			17	17	12	5
	(1) p = 0.012, (2) p = 0.17, (3) p = 0.002, and (4) p = 0.06
Mean A1C levels (in %)
Beginning of the study		7.28			8.21	7.76	8.67
End of the study		7.39			7.88	7.82	7.95
(1) p = 0.08, (2) p = 0.843, (3) p = 0.003, and (4) p = 0.009
Mean DSMP score (in absolute points)
Beginning of the study		53.43			45.02	47.04	43.00
End of the study		52.39			48.58	52.81	44.35
(1) p = 0.013, (2) p = 0.002, (3) p = 0.28, and (4) p = 0.04

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[1] Correspondence to: Felipe Martins de Oliveira, Associação de Diabetes de Ourinhos, Rua Silva Jardim, 838 19900-261 – Ourinhos, SP, Brasil fmo.endocrinologia@gmail.com